isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

isosorbide mononitrate 60 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1632
Product ID 67046-1632_46b2f5a6-295b-3549-e063-6394a90a514d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075522
Listing Expiration 2026-12-31
Marketing Start 2025-12-24

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 670461632
Hyphenated Format 67046-1632

Supplemental Identifiers

RxCUI
353538
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 ANDA075522 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1632-3)
source: ndc

Packages (1)

67046-1632-3 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1632-3)

Ingredients (1)

isosorbide mononitrate (60 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": "46b2f5a6-295b-3549-e063-6394a90a514d", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["353538"], "spl_set_id": ["46b3030d-f492-da9d-e063-6294a90a31b3"], "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, EXTENDED RELEASE in 1 BLISTER PACK (67046-1632-3)", "package_ndc": "67046-1632-3", "marketing_start_date": "20251224"}], "brand_name": "Isosorbide Mononitrate", "product_id": "67046-1632_46b2f5a6-295b-3549-e063-6394a90a514d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "67046-1632", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "60 mg/1"}], "application_number": "ANDA075522", "marketing_category": "ANDA", "marketing_start_date": "20251224", "listing_expiration_date": "20261231"}