isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 20 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6620
Product ID 0904-6620_1c266d12-d95e-4e1b-bd31-a2104ba835e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088088
Listing Expiration 2026-12-31
Marketing Start 1983-04-26

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 09046620
Hyphenated Format 0904-6620

Supplemental Identifiers

RxCUI
206842 381056
UNII
IA7306519N
NUI
N0000175415 M0014874 N0000009909

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 (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number ANDA088088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6620-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6620-61 100 BLISTER PACK in 1 CARTON (0904-6620-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

isosorbide dinitrate (20 mg/1)

Linked Drug Pages (1)

Isosorbide Dinitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1c266d12-d95e-4e1b-bd31-a2104ba835e6", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["206842", "381056"], "spl_set_id": ["6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6620-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6620-61", "marketing_start_date": "19830426"}], "brand_name": "Isosorbide Dinitrate", "product_id": "0904-6620_1c266d12-d95e-4e1b-bd31-a2104ba835e6", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0904-6620", "generic_name": "Isosorbide Dinitrate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "ANDA088088", "marketing_category": "ANDA", "marketing_start_date": "19830426", "listing_expiration_date": "20261231"}