NDC Code(s) : 67877-511-90, 67877-511-05, 67877-511-10, 67877-511-55, 67877-511-33, 67877-511-38, 67877-512-90, 67877-512-05, 67877-512-10, 67877-512-44, 67877-512-33, 67877-512-38, 67877-513-90, 67877-513-05, 67877-513-10, 67877-513-23, 67877-513-33, 67877-513-38, 67877-514-90, 67877-514-05, 67877-514-10, 67877-514-33, 67877-514-38
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-511
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
CALCIUM CARBONATE(UNII: H0G9379FGK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 10 mm
Flavor Imprint Code 10;ATS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-511-9090 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
2NDC:67877-511-05500 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
3NDC:67877-511-101000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
4NDC:67877-511-555000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
5NDC:67877-511-3810 in 1 CARTON 23/12/2018
5NDC:67877-511-3310 in 1 BLISTER PACK Type 0: Not a Combination Product23/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209288 12/23/2018
Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-512
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
CALCIUM CARBONATE(UNII: H0G9379FGK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 12 mm
Flavor Imprint Code 20;ATS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-512-9090 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
2NDC:67877-512-05500 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
3NDC:67877-512-101000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
4NDC:67877-512-444000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
5NDC:67877-512-3810 in 1 CARTON 23/12/2018
5NDC:67877-512-3310 in 1 BLISTER PACK Type 0: Not a Combination Product23/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209288 12/23/2018
Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-513
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
CALCIUM CARBONATE(UNII: H0G9379FGK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 15 mm
Flavor Imprint Code 40;ATS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-513-9090 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
2NDC:67877-513-05500 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
3NDC:67877-513-101000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
4NDC:67877-513-232000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
5NDC:67877-513-3810 in 1 CARTON 23/12/2018
5NDC:67877-513-3310 in 1 BLISTER PACK Type 0: Not a Combination Product23/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209288 12/23/2018
Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-514
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
CALCIUM CARBONATE(UNII: H0G9379FGK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL (elliptical) Size 19 mm
Flavor Imprint Code 80;ATS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-514-9090 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
2NDC:67877-514-05500 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
3NDC:67877-514-101000 in 1 BOTTLE Type 0: Not a Combination Product23/12/2018
4NDC:67877-514-3810 in 1 CARTON 23/12/2018
4NDC:67877-514-3310 in 1 BLISTER PACK Type 0: Not a Combination Product23/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209288 12/23/2018

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(67877-511, 67877-512, 67877-513, 67877-514)

PRINCIPAL DISPLAY PANEL

Atorvastatin Calcium Tablets, USP 10 mg

90 Tablets

NDC 67877-511-90

atorvastatin-10mg-90s-tab-1

Atorvastatin Calcium Tablets, USP 20 mg

500 Tablets

NDC 67877-512-05

atorvastatin-10mg-90s-tab-1

Atorvastatin Caclium Tablets, USP 40 mg

1000 Tablets

NDC 67877-513-10

 atorvastatin-10mg-90s-tab-1

Atorvastatin Caclium Tablets, USP 80 mg

1000 Tablets

NDC 67877-514-10

atorvastatin-10mg-90s-tab-1

Atorvastatin Calcium Tablets, USP 10 mg

100 (10 X 10 Unit-dose Tablets)

NDC 67877-511-38

atorvastatin-10mg-90s-tab-1
 

Atorvastatin Calcium Tablet, USP 10 mg

10 Unit-dose Tablets

NDC 67877-511-33

 atorvastatin-10mg-90s-tab-1