Hydralazine Hydrochloride
HydrALAZINE hydrochloride Tablets, USP Rx only
Approved
Approval ID
0c7f9bd0-6c0a-4521-b77a-3582faa96874
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-582
Application NumberANDA086242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-579
Application NumberANDA086242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-580
Application NumberANDA086242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-581
Application NumberANDA086242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT