NDC Code(s) : 57237-142-01, 57237-142-05, 57237-143-01, 57237-143-05, 57237-144-01, 57237-144-05, 57237-145-01, 57237-145-05, 57237-146-01, 57237-146-05, 57237-147-01, 57237-147-05
Packager : Rising Pharma Holdings, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code I;96
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-142-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
2NDC:57237-142-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012
Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BROWN (Light Brown) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code I;97
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-143-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
2NDC:57237-143-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012
Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-144
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code I;98
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-144-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
2NDC:57237-144-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012
Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code J;01
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-145-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
2NDC:57237-145-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012
Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-146
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color PURPLE Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code J;02
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-146-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
2NDC:57237-146-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012
Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-147
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color BLUE (Dark Blue) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code J;03
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-147-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
2NDC:57237-147-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012

LABELER - Rising Pharma Holdings, Inc.(116880195)

REGISTRANT - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 650381903 ANALYSIS(57237-142, 57237-143, 57237-144, 57237-145, 57237-146, 57237-147), MANUFACTURE(57237-142, 57237-143, 57237-144, 57237-145, 57237-146, 57237-147)

PRINCIPAL DISPLAY PANEL


Rising®         NDC 57237-142-01 
Pharmaceuticals

Amlodipine and
Benazepril
Hydrochloride
Capsules USP 
2.5 mg*/10 mg

100 Capsules               Rx only



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2.5 mg/10 mg (100 Capsules Bottle)



  


PRINCIPAL DISPLAY PANEL


Rising®       NDC 57237-143-01 
Pharmaceuticals

Amlodipine and
Benazepril
Hydrochloride
Capsules USP 
5 mg*/10 mg

100 Capsules        Rx only 
                
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/10 mg (100 Capsules Bottle)              


  


PRINCIPAL DISPLAY PANEL


Rising®       NDC 57237-144-01 
Pharmaceuticals

Amlodipine and
Benazepril
Hydrochloride
Capsules USP 
5 mg*/20 mg

100 Capsules      Rx only      

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/20 mg (100 Capsules Bottle)                        



  


PRINCIPAL DISPLAY PANEL


Rising®       NDC 57237-145-01 
Pharmaceuticals

Amlodipine and
Benazepril Hydrochloride
Capsules USP 
5 mg*/40 mg

100 Capsules             Rx only 

figure                          




PRINCIPAL DISPLAY PANEL


Rising®     NDC 57237-146-01 
Pharmaceuticals

Amlodipine and
Benazepril
Hydrochloride
Capsules USP 
10 mg*/20 mg

100 Capsules     Rx only   

figure                           


  


PRINCIPAL DISPLAY PANEL


Rising®                         NDC 57237-147-01
Pharmaceuticals
Amlodipine and
Benazepril Hydrochloride
Capsules USP 
10 mg*/40 mg

100 Capsules      Rx only 

figure