isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide mononitrate 20 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1578
Product ID 67046-1578_3e0e00c9-653e-fa76-e063-6294a90a2bff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020215
Listing Expiration 2026-12-31
Marketing Start 2025-09-05

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 670461578
Hyphenated Format 67046-1578

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1578-3)
source: ndc

Packages (1)

67046-1578-3 30 TABLET in 1 BLISTER PACK (67046-1578-3)

Ingredients (1)

isosorbide mononitrate (20 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": "3e0e00c9-653e-fa76-e063-6294a90a2bff", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["311197"], "spl_set_id": ["3e0e013f-6887-fa72-e063-6294a90a18ca"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1578-3)", "package_ndc": "67046-1578-3", "marketing_start_date": "20250905"}], "brand_name": "isosorbide mononitrate", "product_id": "67046-1578_3e0e00c9-653e-fa76-e063-6294a90a2bff", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "67046-1578", "generic_name": "isosorbide mononitrate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "isosorbide mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "20 mg/1"}], "application_number": "NDA020215", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250905", "listing_expiration_date": "20261231"}