isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide mononitrate 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-900
Product ID 63187-900_44ed966d-bf75-4379-84f4-b5270e2bb700
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020215
Listing Expiration 2026-12-31
Marketing Start 1993-06-30

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 63187900
Hyphenated Format 63187-900

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 BOTTLE (63187-900-30)
  • 60 TABLET in 1 BOTTLE (63187-900-60)
  • 90 TABLET in 1 BOTTLE (63187-900-90)
source: ndc

Packages (3)

63187-900-30 30 TABLET in 1 BOTTLE (63187-900-30) 63187-900-60 60 TABLET in 1 BOTTLE (63187-900-60) 63187-900-90 90 TABLET in 1 BOTTLE (63187-900-90)

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": "44ed966d-bf75-4379-84f4-b5270e2bb700", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["311197"], "spl_set_id": ["f871dfa7-219f-4704-8e4d-215caeb7408d"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-900-30)", "package_ndc": "63187-900-30", "marketing_start_date": "20170901"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-900-60)", "package_ndc": "63187-900-60", "marketing_start_date": "20170901"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-900-90)", "package_ndc": "63187-900-90", "marketing_start_date": "20170901"}], "brand_name": "isosorbide mononitrate", "product_id": "63187-900_44ed966d-bf75-4379-84f4-b5270e2bb700", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "63187-900", "generic_name": "isosorbide mononitrate", "labeler_name": "Proficient Rx LP", "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": "19930630", "listing_expiration_date": "20261231"}