captopril
Captopril Tablets, USPRx only
Approved
Approval ID
1395ba5b-2fc9-41ff-9c43-e0740d781dee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2022
Manufacturers
FDA
AMICI PHARMACEUTICALS LLC
DUNS: 079536824
Products 4
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 Code69292-522
Application NumberANDA074677
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (5)
CAPTOPRILActive
Quantity: 12.5 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-526
Application NumberANDA074677
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (5)
CAPTOPRILActive
Quantity: 50 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-524
Application NumberANDA074677
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CAPTOPRILActive
Quantity: 25 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-528
Application NumberANDA074677
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (5)
CAPTOPRILActive
Quantity: 100 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT