NDC Code(s) : 69097-677-02, 69097-677-05, 69097-677-12, 69097-677-19, 69097-677-21, 69097-678-02, 69097-678-05, 69097-678-12, 69097-678-19, 69097-678-21, 69097-679-02, 69097-679-05, 69097-679-12, 69097-679-19, 69097-679-21, 69097-681-02, 69097-681-05, 69097-681-12, 69097-681-19, 69097-681-21, 69097-682-02, 69097-682-05, 69097-682-12, 69097-682-19, 69097-682-21, 69097-683-02, 69097-683-05, 69097-683-12, 69097-683-19, 69097-683-21, 69097-684-02, 69097-684-05, 69097-684-12, 69097-684-19, 69097-684-21, 69097-685-02, 69097-685-05, 69097-685-12, 69097-685-19, 69097-685-21
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-677
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Cipla25mg;677
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-677-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-677-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-677-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-677-21100 in 1 CARTON 01/10/2020
4NDC:69097-677-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-678
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN50 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code Cipla50mg;678
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-678-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-678-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-678-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-678-21100 in 1 CARTON 01/10/2020
4NDC:69097-678-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-679
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN75 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color ORANGE ((white)) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Cipla75mg;679
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-679-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-679-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-679-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-679-21100 in 1 CARTON 01/10/2020
4NDC:69097-679-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-681
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN100 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code Cipla100mg;681
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-681-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-681-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-681-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-681-21100 in 1 CARTON 01/10/2020
4NDC:69097-681-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-682
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN150 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code Cipla150mg;682
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-682-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-682-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-682-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-682-21100 in 1 CARTON 01/10/2020
4NDC:69097-682-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-683
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN200 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code Cipla200mg;683
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-683-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-683-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-683-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-683-21100 in 1 CARTON 01/10/2020
4NDC:69097-683-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-684
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN225 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color ORANGE ((white)) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code Cipla225mg;684
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-684-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-684-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-684-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-684-21100 in 1 CARTON 01/10/2020
4NDC:69097-684-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020
PREGABALIN capsules, CV PREGABALIN capsules, CV CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-685
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN300 mg
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
WATER(UNII: 059QF0KO0R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color ORANGE ((white)) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code Cipla300mg;685
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-685-0230 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
2NDC:69097-685-0590 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
3NDC:69097-685-12500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2020
4NDC:69097-685-21100 in 1 CARTON 01/10/2020
4NDC:69097-685-1910 in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212280 01/10/2020

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Limited- Kurkumbh 917066446 MANUFACTURE(69097-677, 69097-678, 69097-679, 69097-681, 69097-682, 69097-683, 69097-684, 69097-685)

Establishment
Name Address ID/FEI Business Operations
MSN Pharmachem Private Limited 677318200 ANALYSIS(69097-677, 69097-678, 69097-679, 69097-681, 69097-682, 69097-683, 69097-684, 69097-685), API MANUFACTURE(69097-677, 69097-678, 69097-679, 69097-681, 69097-682, 69097-683, 69097-684, 69097-685)

PRINCIPAL DISPLAY PANEL

NDC 69097- 677-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     25 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 677-05                             Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     25 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 678-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     50 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 678-0 5                            Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     50 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 679-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     75 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 679-05                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     75 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 681-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     100 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 681-05                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     100 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 682-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     150 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 682-05                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     150 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 683-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     200 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 683-05                             Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     200 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 684-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     225 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 684-05                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     225 mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton

NDC 69097- 685-21                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     300 mg

                           PHARMACIST :

               Dispense the Medication Guide

            Provided separately to each patient

                     For in-institution use only

               100 Capsules (10 x 10 Unit-Dose)

                                       Cipla

25 carton

NDC 69097- 685-05                              Rx Only

                                 Pregabalin  Cv

                                    Capsules

 

                                     300mg

                           PHARMACIST :

               Dispense the accompanying

            Medication Guide to each patient

                               90 capsules                                     

                                    Cipla

25 carton