NDC 50742-246

Isosorbide dinitrate and hydralazine hydrochloride

Isosorbide Dinitrate And Hydralazine Hydrochloride

Isosorbide dinitrate and hydralazine hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Hydralazine Hydrochloride; Isosorbide Dinitrate.

Product ID50742-246_62228a4b-3e48-471c-9e51-37bf1f44cb7b
NDC50742-246
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide dinitrate and hydralazine hydrochloride
Generic NameIsosorbide Dinitrate And Hydralazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-02-12
Marketing CategoryANDA /
Application NumberANDA215586
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameHYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Active Ingredient Strength38 mg/1; mg/1
Pharm ClassesArteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50742-246-18

180 TABLET in 1 BOTTLE (50742-246-18)
Marketing Start Date2022-02-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Isosorbide dinitrate and hydralazine hydrochloride" or generic name "Isosorbide Dinitrate And Hydralazine Hydrochloride"

NDCBrand NameGeneric Name
50742-246Isosorbide dinitrate and hydralazine hydrochlorideIsosorbide dinitrate and hydralazine hydrochloride
52536-006isosorbide dinitrate and hydralazine hydrochloridehydralazine hydrochloride and isosorbide dinitrate

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