Amlodipine Besylate and Benazepril Hydrochloride
These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
Approved
Approval ID
c95fe9f4-fb64-41b1-a61f-85b102d09929
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amlodipine Besylate and Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6297
Application NumberANDA090149
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate and Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2011
FDA Product Classification
INGREDIENTS (14)
benazepril hydrochlorideActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIM
amlodipine besylateActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT