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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

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