isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-117
Product ID 82804-117_33d14f59-3ae8-4414-b826-06274cf0f3d9
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 82804117
Hyphenated Format 82804-117

Supplemental Identifiers

RxCUI
381056
UPC
0382804117901
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
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (82804-117-90)
source: ndc

Packages (1)

82804-117-90 90 TABLET in 1 BOTTLE (82804-117-90)

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": "33d14f59-3ae8-4414-b826-06274cf0f3d9", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0382804117901"], "unii": ["IA7306519N"], "rxcui": ["381056"], "spl_set_id": ["33d14f59-3ae8-4414-b826-06274cf0f3d9"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-117-90)", "package_ndc": "82804-117-90", "marketing_start_date": "20240711"}], "brand_name": "ISOSORBIDE DINITRATE", "product_id": "82804-117_33d14f59-3ae8-4414-b826-06274cf0f3d9", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "82804-117", "generic_name": "isosorbide dinitrate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE DINITRATE", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "10 mg/1"}], "application_number": "ANDA215723", "marketing_category": "ANDA", "marketing_start_date": "20220708", "listing_expiration_date": "20261231"}