Hydralazine Hydrochloride
HYDRALAZINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
5da36930-d3da-4b5c-9e22-2b141bc01a9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2019
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-522
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (6)
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-519
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (6)
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-520
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-521
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT