isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: omnivium pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler omnivium pharmaceuticals llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide mononitrate 10 mg/1

Manufacturer
OMNIVIUM PHARMACEUTICALS LLC.

Identifiers & Regulatory

Product NDC 81665-102
Product ID 81665-102_dba5d0c5-88bc-4091-b882-43dddc70923e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020215
Listing Expiration 2026-12-31
Marketing Start 2024-05-02

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 81665102
Hyphenated Format 81665-102

Supplemental Identifiers

RxCUI
311192 311197
UPC
0381665103108
UNII
LX1OH63030
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 mononitrate (source: ndc)
Generic Name isosorbide mononitrate (source: ndc)
Application Number NDA020215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (81665-102-10)
source: ndc

Packages (1)

81665-102-10 100 TABLET in 1 BOTTLE (81665-102-10)

Ingredients (1)

isosorbide mononitrate (10 mg/1)

Linked Drug Pages (1)

isosorbide mononitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dba5d0c5-88bc-4091-b882-43dddc70923e", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0381665103108"], "unii": ["LX1OH63030"], "rxcui": ["311192", "311197"], "spl_set_id": ["cdf01e14-778b-4b3f-8372-1c18f266fb98"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["OMNIVIUM PHARMACEUTICALS LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (81665-102-10)", "package_ndc": "81665-102-10", "marketing_start_date": "20240502"}], "brand_name": "isosorbide mononitrate", "product_id": "81665-102_dba5d0c5-88bc-4091-b882-43dddc70923e", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "81665-102", "generic_name": "isosorbide mononitrate", "labeler_name": "OMNIVIUM PHARMACEUTICALS LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "isosorbide mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "10 mg/1"}], "application_number": "NDA020215", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240502", "listing_expiration_date": "20261231"}