Captopril
Captopril Tablets, USP for oral use Rx only
Approved
Approval ID
2d3779b0-83d9-4b6f-a043-f7768cd7fce6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2023
Manufacturers
FDA
Solco Healthcare US, LLC
DUNS: 828343017
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 Code43547-364
Application NumberANDA074477
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (5)
CAPTOPRILActive
Quantity: 25 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-365
Application NumberANDA074477
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CAPTOPRILActive
Quantity: 50 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
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-363
Application NumberANDA074477
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (5)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CAPTOPRILActive
Quantity: 12.5 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-366
Application NumberANDA074477
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (5)
CAPTOPRILActive
Quantity: 100 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT