isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide mononitrate 20 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2620
Product ID 0228-2620_1cb05f66-1c19-4300-8745-8c74c1dccb2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075037
Marketing Start 1998-10-30
Marketing End 2027-04-30

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 02282620
Hyphenated Format 0228-2620

Supplemental Identifiers

RxCUI
311192 311197
UPC
0302282631119 0302282620113
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 ANDA075037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0228-2620-11)
source: ndc

Packages (1)

0228-2620-11 100 TABLET in 1 BOTTLE (0228-2620-11)

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": "1cb05f66-1c19-4300-8745-8c74c1dccb2b", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0302282631119", "0302282620113"], "unii": ["LX1OH63030"], "rxcui": ["311192", "311197"], "spl_set_id": ["ae8f74f0-e600-4452-8557-958b603e2709"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0228-2620-11)", "package_ndc": "0228-2620-11", "marketing_end_date": "20270430", "marketing_start_date": "19981030"}], "brand_name": "Isosorbide Mononitrate", "product_id": "0228-2620_1cb05f66-1c19-4300-8745-8c74c1dccb2b", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0228-2620", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "20 mg/1"}], "application_number": "ANDA075037", "marketing_category": "ANDA", "marketing_end_date": "20270430", "marketing_start_date": "19981030"}