Amlodipine Besylate and Benazepril Hydrochloride (Page 7 of 7)

Amlodipine Besylate and Benazepril Hydrochloride

Label ImageLabel Image
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5357(NDC:68180-463)
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
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN (dark green cap) , WHITE (white body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5357-0 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/05/2011
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5357), REPACK (50090-5357)

Revised: 09/2023 A-S Medication Solutions

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