isosorbide dinitrate (72888-083)

Drug Facts

Product Profile

Brand Name isosorbide dinitrate

Generic Name isosorbide dinitrate

Labeler advagen pharma ltd

Dosage Form TABLET

Routes

ORAL

Active Ingredients

isosorbide dinitrate 20 mg/1

Manufacturer

Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-083

Product ID 72888-083_47a16566-2f2d-7df8-e063-6394a90a9012

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215723

Listing Expiration 2027-12-31

Marketing Start 2022-07-08

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 72888083

Hyphenated Format 72888-083

Supplemental Identifiers

RxCUI

197839 197840 206842 314055 381056

UPC

0372888082004 0372888083001 0372888084008 0372888081007 0372888082011 0372888081014 0372888083018 0372888084015 0372888085005 0372888085012

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 ANDA215723 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

1000 TABLET in 1 BOTTLE (72888-083-00)
100 TABLET in 1 BOTTLE (72888-083-01)

source: ndc

Packages (2)

72888-083-00 1000 TABLET in 1 BOTTLE (72888-083-00) 72888-083-01 100 TABLET in 1 BOTTLE (72888-083-01)

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": "47a16566-2f2d-7df8-e063-6394a90a9012", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0372888082004", "0372888083001", "0372888084008", "0372888081007", "0372888082011", "0372888081014", "0372888083018", "0372888084015", "0372888085005", "0372888085012"], "unii": ["IA7306519N"], "rxcui": ["197839", "197840", "206842", "314055", "381056"], "spl_set_id": ["b166eb5b-bad8-4663-9c05-1c43539dab2c"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-083-00)", "package_ndc": "72888-083-00", "marketing_start_date": "20220708"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-083-01)", "package_ndc": "72888-083-01", "marketing_start_date": "20220708"}], "brand_name": "ISOSORBIDE DINITRATE", "product_id": "72888-083_47a16566-2f2d-7df8-e063-6394a90a9012", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "72888-083", "generic_name": "isosorbide dinitrate", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE DINITRATE", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "ANDA215723", "marketing_category": "ANDA", "marketing_start_date": "20220708", "listing_expiration_date": "20271231"}