Amlodipine Besylate and Benazepril Hydrochloride
These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use.Initial U.S. Approval: 1995
Approved
Approval ID
c695f95d-6064-4a22-84ba-c8e62477b3a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5357
Application NumberANDA078466
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate and Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (17)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT