isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler sandoz inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 20 mg/1

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 0781-1695
Product ID 0781-1695_9c848a4f-2720-4c80-a0be-e49200cb10f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089367
Listing Expiration 2026-12-31
Marketing Start 1988-01-07

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 07811695
Hyphenated Format 0781-1695

Supplemental Identifiers

RxCUI
206842 314055 381056
UPC
0307811556017 0307811695013 0307811635019
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 ANDA089367 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0781-1695-01)
  • 1000 TABLET in 1 BOTTLE (0781-1695-10)
source: ndc

Packages (2)

0781-1695-01 100 TABLET in 1 BOTTLE (0781-1695-01) 0781-1695-10 1000 TABLET in 1 BOTTLE (0781-1695-10)

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": "9c848a4f-2720-4c80-a0be-e49200cb10f9", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0307811556017", "0307811695013", "0307811635019"], "unii": ["IA7306519N"], "rxcui": ["206842", "314055", "381056"], "spl_set_id": ["71fdd147-a987-40b6-9f07-82d56525ceb8"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0781-1695-01)", "package_ndc": "0781-1695-01", "marketing_start_date": "19880107"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0781-1695-10)", "package_ndc": "0781-1695-10", "marketing_start_date": "19880107"}], "brand_name": "Isosorbide Dinitrate", "product_id": "0781-1695_9c848a4f-2720-4c80-a0be-e49200cb10f9", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0781-1695", "generic_name": "Isosorbide Dinitrate", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "ANDA089367", "marketing_category": "ANDA", "marketing_start_date": "19880107", "listing_expiration_date": "20261231"}