Package 72319-012-03

Brand: isosorbide dinitrate and hydralazine hydrochloride

Generic: isosorbide dinitrate and hydralazine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 72319-012-03
Digits Only 7231901203
Product NDC 72319-012
Description

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

Marketing

Marketing Status
Marketed Since 2024-02-07
Brand isosorbide dinitrate and hydralazine hydrochloride
Generic isosorbide dinitrate and hydralazine hydrochloride
Sample Package No

Linked Drug Pages (1)

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"}