Amlodipine and Benazepril Hydrochloride (Page 6 of 6)

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Amlodipine and Benazepril Hydrochloride

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Amlodipine and Benazepril Hydrochloride

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AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE amlodipine and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2720(NDC:65862-587)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color BLUE (Dark Blue) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code J;03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2720-0 90 CAPSULE in 1 BOTTLE None
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 Item Code (Source) NDC:50090-3049(NDC:65862-585)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code J;01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3049-0 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202239 09/05/2012 12/31/2021
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2720), REPACK (50090-2720), RELABEL (50090-3049), REPACK (50090-3049)

Revised: 01/2024 A-S Medication Solutions

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