isosorbide dinitrate and hydralazine hydrochloride
These highlights do not include all the information needed to use ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLETS. ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE tablet, for oral use Initial U.S. Approval: 2005
Approved
Approval ID
620a0680-aad0-4923-84be-7393c0cbdcbd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2022
Manufacturers
FDA
Wilshire Pharmaceuticals
DUNS: 078657245
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydralazine hydrochloride and isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52536-006
Application NumberNDA020727
Product Classification
M
Marketing Category
C73605
G
Generic Name
hydralazine hydrochloride and isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2020
FDA Product Classification
INGREDIENTS (12)
Isosorbide dinitrateActive
Quantity: 20 mg in 1 1
Code: IA7306519N
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Hydralazine hydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT