Amlodipine Besylate and Benazepril Hydrochloride (Page 7 of 7)

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NDC: 82868-041-90

Label
(click image for full-size original)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82868-041(NDC:55111-341)
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 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
HYDROGENATED CASTOR OIL
FERROSOFERRIC OXIDE
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color gray (ivory) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;341
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82868-041-90 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077183 01/19/2024
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (82868-041)

Revised: 01/2024 Northwind Pharmaceuticals, LLC

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