isosorbide dinitrate and hydralazine hydrochloride (50742-246)

Drug Facts

Product Profile

Brand Name isosorbide dinitrate and hydralazine hydrochloride

Generic Name isosorbide dinitrate and hydralazine hydrochloride

Labeler ingenus pharmaceuticals, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydralazine hydrochloride 37.5 mg/1, isosorbide dinitrate 20 mg/1

Manufacturer

Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-246

Product ID 50742-246_3ba1968f-1fbf-4136-8bcd-c2af2fc93a83

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215586

Listing Expiration 2026-12-31

Marketing Start 2022-04-12

Pharmacologic Class

Established (EPC)

nitrate vasodilator [epc]

Chemical Structure

nitrates [cs]

Physiologic Effect

vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742246

Hyphenated Format 50742-246

Supplemental Identifiers

RxCUI

905377

UPC

0350742246908 0350742246182

UNII

FD171B778Y IA7306519N

NUI

N0000175415 M0014874 N0000009909

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isosorbide dinitrate and hydralazine hydrochloride (source: ndc)

Generic Name isosorbide dinitrate and hydralazine hydrochloride (source: ndc)

Application Number ANDA215586 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

37.5 mg/1
20 mg/1

source: ndc

Packaging

180 TABLET in 1 BOTTLE (50742-246-18)
90 TABLET in 1 BOTTLE (50742-246-90)

source: ndc

Packages (2)

50742-246-18 180 TABLET in 1 BOTTLE (50742-246-18) 50742-246-90 90 TABLET in 1 BOTTLE (50742-246-90)

Ingredients (2)

hydralazine hydrochloride (37.5 mg/1) isosorbide dinitrate (20 mg/1)

Linked Drug Pages (1)

Isosorbide dinitrate and hydralazine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3ba1968f-1fbf-4136-8bcd-c2af2fc93a83", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0350742246908", "0350742246182"], "unii": ["FD171B778Y", "IA7306519N"], "rxcui": ["905377"], "spl_set_id": ["8f54d5a3-169f-48dd-9250-2c176d2bd9ad"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (50742-246-18)", "package_ndc": "50742-246-18", "marketing_start_date": "20220412"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50742-246-90)", "package_ndc": "50742-246-90", "marketing_start_date": "20220412"}], "brand_name": "Isosorbide dinitrate and hydralazine hydrochloride", "product_id": "50742-246_3ba1968f-1fbf-4136-8bcd-c2af2fc93a83", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]", "Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "50742-246", "generic_name": "Isosorbide dinitrate and hydralazine hydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide dinitrate and hydralazine hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "37.5 mg/1"}, {"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "ANDA215586", "marketing_category": "ANDA", "marketing_start_date": "20220412", "listing_expiration_date": "20261231"}