HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
e9888fe1-a2ed-41b5-b5dd-df7fff3fad37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-694
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (6)
Hydralazine hydrochlorideActive
Quantity: 50 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
Anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code21695-679
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Hydralazine hydrochlorideActive
Quantity: 10 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-695
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (6)
Hydralazine hydrochlorideActive
Quantity: 100 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
Anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
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
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-680
Application NumberANDA040901
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (6)
Hydralazine hydrochlorideActive
Quantity: 25 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
Anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT