isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

isosorbide mononitrate 60 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6450
Product ID 0904-6450_af7ec13d-7e9f-4407-9588-f61a75bac043
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200495
Listing Expiration 2026-12-31
Marketing Start 2015-01-05

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 09046450
Hyphenated Format 0904-6450

Supplemental Identifiers

RxCUI
317110 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 ANDA200495 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6450-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6450-61 100 BLISTER PACK in 1 CARTON (0904-6450-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "af7ec13d-7e9f-4407-9588-f61a75bac043", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["317110", "353538"], "spl_set_id": ["8cbb364a-bafe-454b-a53f-bd7cd69a5593"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6450-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6450-61", "marketing_start_date": "20150105"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "0904-6450_af7ec13d-7e9f-4407-9588-f61a75bac043", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0904-6450", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE MONONITRATE", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "60 mg/1"}], "application_number": "ANDA200495", "marketing_category": "ANDA", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}