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
bba29c25-611c-4225-8fa7-d7723611abbc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-1802
Application NumberANDA090149
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate and Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (15)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT