isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler oceanside pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 5 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-193
Product ID 68682-193_723d9f78-9d77-4575-af27-1aa117e6b8d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA012093
Listing Expiration 2026-12-31
Marketing Start 2020-03-02

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 68682193
Hyphenated Format 68682-193

Supplemental Identifiers

RxCUI
197840 314055
UPC
0368682193015
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 NDA012093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68682-193-01)
source: ndc

Packages (1)

68682-193-01 100 TABLET in 1 BOTTLE (68682-193-01)

Ingredients (1)

isosorbide dinitrate (5 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": "723d9f78-9d77-4575-af27-1aa117e6b8d7", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0368682193015"], "unii": ["IA7306519N"], "rxcui": ["197840", "314055"], "spl_set_id": ["723d9f78-9d77-4575-af27-1aa117e6b8d7"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68682-193-01)", "package_ndc": "68682-193-01", "marketing_start_date": "20200302"}], "brand_name": "Isosorbide Dinitrate", "product_id": "68682-193_723d9f78-9d77-4575-af27-1aa117e6b8d7", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "68682-193", "generic_name": "isosorbide dinitrate", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "5 mg/1"}], "application_number": "NDA012093", "marketing_category": "NDA", "marketing_start_date": "20200302", "listing_expiration_date": "20261231"}