Captopril
Captopril Tablets, USPRev. 01/12Rx Only
Approved
Approval ID
1e1eb843-4fcd-4329-94ec-720a52970253
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3724
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
FDA Product Classification
INGREDIENTS (7)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CAPTOPRILActive
Quantity: 25 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5196
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CAPTOPRILActive
Quantity: 100 mg in 1 1
Code: 9G64RSX1XD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code54868-3723
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Captopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3725
Application NumberANDA074505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Captopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
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