Amlobenz
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
241e7477-ecae-4f84-8410-bbfaa9f57ed0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amlobenz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-866
Application NumberANDA077183
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlobenz
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2010
FDA Product Classification
INGREDIENTS (12)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: N1SN99T69T
Classification: ACTIM
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT