isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 10 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-1771
Product ID 0143-1771_9be99742-a98b-46d3-9447-81b45679fff9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088088
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 01431771
Hyphenated Format 0143-1771

Supplemental Identifiers

RxCUI
206842 314055 381056
UPC
0301431769017 0301431771010 0301431772017
UNII
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 (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number ANDA088088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0143-1771-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1771-10)
source: ndc

Packages (2)

0143-1771-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1771-01) 0143-1771-10 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1771-10)

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": "9be99742-a98b-46d3-9447-81b45679fff9", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0301431769017", "0301431771010", "0301431772017"], "unii": ["IA7306519N"], "rxcui": ["206842", "314055", "381056"], "spl_set_id": ["f0b9b320-0bf8-4342-b654-135ccb6755c2"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0143-1771-01)", "package_ndc": "0143-1771-01", "marketing_start_date": "19781201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0143-1771-10)", "package_ndc": "0143-1771-10", "marketing_start_date": "19781201"}], "brand_name": "Isosorbide Dinitrate", "product_id": "0143-1771_9be99742-a98b-46d3-9447-81b45679fff9", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0143-1771", "generic_name": "Isosorbide Dinitrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "10 mg/1"}], "application_number": "ANDA088088", "marketing_category": "ANDA", "marketing_start_date": "19781201", "listing_expiration_date": "20261231"}