isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 30 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8465
Product ID 0615-8465_e52655b8-2c52-4534-9f86-bb70ebff3321
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215723
Listing Expiration 2026-12-31
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 06158465
Hyphenated Format 0615-8465

Supplemental Identifiers

RxCUI
197839 206842 381056
UNII
IA7306519N
NUI
N0000175415 M0014874 N0000009909

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
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8465-39)
source: ndc

Packages (1)

0615-8465-39 30 TABLET in 1 BLISTER PACK (0615-8465-39)

Ingredients (1)

isosorbide dinitrate (30 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": "e52655b8-2c52-4534-9f86-bb70ebff3321", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["197839", "206842", "381056"], "spl_set_id": ["74a7f767-fa2f-4640-be24-34a8a9128217"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8465-39)", "package_ndc": "0615-8465-39", "marketing_start_date": "20230501"}], "brand_name": "ISOSORBIDE DINITRATE", "product_id": "0615-8465_e52655b8-2c52-4534-9f86-bb70ebff3321", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0615-8465", "generic_name": "isosorbide dinitrate", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE DINITRATE", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "30 mg/1"}], "application_number": "ANDA215723", "marketing_category": "ANDA", "marketing_start_date": "20220708", "listing_expiration_date": "20261231"}