CAPTOPRIL
CAPTOPRIL TABLETS, USP
Approved
Approval ID
2f87bcd5-6fc8-4084-9644-519fa5ee8a6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2021
Manufacturers
FDA
Windlas Biotech Limited
DUNS: 854248293
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 Code57721-905
Application NumberANDA074532
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (7)
CAPTOPRILActive
Quantity: 100 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57721-902
Application NumberANDA074532
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (7)
CAPTOPRILActive
Quantity: 12.5 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57721-904
Application NumberANDA074532
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CAPTOPRILActive
Quantity: 50 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57721-903
Application NumberANDA074532
Product Classification
M
Marketing Category
C73584
G
Generic Name
captopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (7)
CAPTOPRILActive
Quantity: 25 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT