isosorbide dinitrate and hydralazine hydrochloride (72319-012)

Drug Facts

Product Profile

Brand Name isosorbide dinitrate and hydralazine hydrochloride

Generic Name isosorbide dinitrate and hydralazine hydrochloride

Labeler i3 pharmaceuticals, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

i3 Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 72319-012

Product ID 72319-012_1898d58a-a951-f2a3-e063-6394a90a5e9f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215988

Listing Expiration 2026-12-31

Marketing Start 2024-02-07

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 72319012

Hyphenated Format 72319-012

Supplemental Identifiers

RxCUI

905377

UPC

0372319012037

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 ANDA215988 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

37.5 mg/1
20 mg/1

source: ndc

Packaging

90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)
180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)

source: ndc

Packages (2)

72319-012-03 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) 72319-012-18 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)

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": "1898d58a-a951-f2a3-e063-6394a90a5e9f", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0372319012037"], "unii": ["FD171B778Y", "IA7306519N"], "rxcui": ["905377"], "spl_set_id": ["cacf1a7c-0388-09ee-e053-2995a90a10cf"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["i3 Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)", "package_ndc": "72319-012-03", "marketing_start_date": "20240207"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)", "package_ndc": "72319-012-18", "marketing_start_date": "20240207"}], "brand_name": "isosorbide dinitrate and hydralazine hydrochloride", "product_id": "72319-012_1898d58a-a951-f2a3-e063-6394a90a5e9f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]", "Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "72319-012", "generic_name": "isosorbide dinitrate and hydralazine hydrochloride", "labeler_name": "i3 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": "ANDA215988", "marketing_category": "ANDA", "marketing_start_date": "20240207", "listing_expiration_date": "20261231"}