Captopril
Captopril Tablets, USP for oral use Rx only
Approved
Approval ID
2baec3fb-e7b0-46b4-a69d-29f6448532bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8727
Application NumberANDA074477
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2019
FDA Product Classification
INGREDIENTS (5)
CAPTOPRILActive
Quantity: 12.5 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT