Package 72319-012-03
Brand: isosorbide dinitrate and hydralazine hydrochloride
Generic: isosorbide dinitrate and hydralazine hydrochloridePackage 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
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"}