Captopril
Rev. 11/19Rx Only
Approved
Approval ID
607687f4-63cf-411c-a20b-21d238a6b7a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-1173
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (7)
CAPTOPRILActive
Quantity: 50 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code0143-1172
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (7)
CAPTOPRILActive
Quantity: 25 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code0143-1171
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (7)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CAPTOPRILActive
Quantity: 12.5 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-1174
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (7)
CAPTOPRILActive
Quantity: 100 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT