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 . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995
Approved
Approval ID
224e9b5b-fa1f-452d-8ce7-d630b18f967f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2012
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-1363
Application NumberNDA020364
Product Classification
M
Marketing Category
C73605
G
Generic Name
amlodipine besylate and benazepril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2013
FDA Product Classification
INGREDIENTS (17)
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CALCIUM PHOSPHATEInactive
Code: 97Z1WI3NDX
Classification: IACT
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT