isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 10 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-7990
Product ID 55154-7990_dde61426-7d3b-40a3-9fd4-f654bfb75693
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086066
Listing Expiration 2026-12-31
Marketing Start 1978-12-01

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 551547990
Hyphenated Format 55154-7990

Supplemental Identifiers

RxCUI
206842 381056
UPC
0055154799003
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 ANDA086066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-7990-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-7990-0 10 BLISTER PACK in 1 BAG (55154-7990-0) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

isosorbide dinitrate (10 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": "dde61426-7d3b-40a3-9fd4-f654bfb75693", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0055154799003"], "unii": ["IA7306519N"], "rxcui": ["206842", "381056"], "spl_set_id": ["5f585259-59ed-4648-b562-164f3746c821"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-7990-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-7990-0", "marketing_start_date": "19781201"}], "brand_name": "Isosorbide Dinitrate", "product_id": "55154-7990_dde61426-7d3b-40a3-9fd4-f654bfb75693", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "55154-7990", "generic_name": "Isosorbide Dinitrate", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "10 mg/1"}], "application_number": "ANDA086066", "marketing_category": "ANDA", "marketing_start_date": "19781201", "listing_expiration_date": "20261231"}