Captopril
Captopril Tablets, USP Rx only
Approved
Approval ID
a43a5373-ded9-4912-8c98-edaec8352836
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2021
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 2
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 Code0904-7105
Application NumberANDA212809
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2021
FDA Product Classification
INGREDIENTS (6)
CAPTOPRILActive
Quantity: 12.5 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
crospovidoneInactive
Code: 2S7830E561
Classification: IACT
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7106
Application NumberANDA212809
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2021
FDA Product Classification
INGREDIENTS (6)
CAPTOPRILActive
Quantity: 25 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
crospovidoneInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT