isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

isosorbide dinitrate 10 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-021
Product ID 49884-021_bb122d4c-8b22-44dd-9c60-772123f18a4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086925
Listing Expiration 2026-12-31
Marketing Start 1979-12-22

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 49884021
Hyphenated Format 49884-021

Supplemental Identifiers

RxCUI
197839 206842 314055 381056
UPC
0349884009014 0349884020019 0349884022013
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 ANDA086925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (49884-021-01)
  • 1000 TABLET in 1 BOTTLE (49884-021-10)
source: ndc

Packages (2)

49884-021-01 100 TABLET in 1 BOTTLE (49884-021-01) 49884-021-10 1000 TABLET in 1 BOTTLE (49884-021-10)

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": "bb122d4c-8b22-44dd-9c60-772123f18a4e", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0349884009014", "0349884020019", "0349884022013"], "unii": ["IA7306519N"], "rxcui": ["197839", "206842", "314055", "381056"], "spl_set_id": ["6df6a2fa-c56c-4eb6-a485-c16585420eb0"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (49884-021-01)", "package_ndc": "49884-021-01", "marketing_start_date": "19791222"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (49884-021-10)", "package_ndc": "49884-021-10", "marketing_start_date": "19791222"}], "brand_name": "Isosorbide Dinitrate", "product_id": "49884-021_bb122d4c-8b22-44dd-9c60-772123f18a4e", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "49884-021", "generic_name": "isosorbide dinitrate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "10 mg/1"}], "application_number": "ANDA086925", "marketing_category": "ANDA", "marketing_start_date": "19791222", "listing_expiration_date": "20261231"}