isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler aurobindo pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 120 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-541
Product ID 59651-541_55810c9d-1140-40b8-a297-210a84afc05a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216557
Listing Expiration 2026-12-31
Marketing Start 2022-11-07

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 59651541
Hyphenated Format 59651-541

Supplemental Identifiers

RxCUI
311196 317110 353538
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 ANDA216557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-541-01)
source: ndc

Packages (1)

59651-541-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-541-01)

Ingredients (1)

isosorbide mononitrate (120 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": "55810c9d-1140-40b8-a297-210a84afc05a", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["311196", "317110", "353538"], "spl_set_id": ["55810c9d-1140-40b8-a297-210a84afc05a"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-541-01)", "package_ndc": "59651-541-01", "marketing_start_date": "20221107"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "59651-541_55810c9d-1140-40b8-a297-210a84afc05a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "59651-541", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE MONONITRATE", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "120 mg/1"}], "application_number": "ANDA216557", "marketing_category": "ANDA", "marketing_start_date": "20221107", "listing_expiration_date": "20261231"}