isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler golden state medical supply, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 30 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-208
Product ID 51407-208_26ab803d-04f8-b766-e063-6394a90a117f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210918
Listing Expiration 2026-12-31
Marketing Start 2018-11-05

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 51407208
Hyphenated Format 51407-208

Supplemental Identifiers

RxCUI
311196 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 ANDA210918 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-208-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-208-05)
source: ndc

Packages (2)

51407-208-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-208-01) 51407-208-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-208-05)

Ingredients (1)

isosorbide mononitrate (30 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": "26ab803d-04f8-b766-e063-6394a90a117f", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["311196", "317110", "353538"], "spl_set_id": ["86be0e85-5337-bee4-e053-2a91aa0a8158"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-208-01)", "package_ndc": "51407-208-01", "marketing_start_date": "20190419"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-208-05)", "package_ndc": "51407-208-05", "marketing_start_date": "20190419"}], "brand_name": "Isosorbide Mononitrate", "product_id": "51407-208_26ab803d-04f8-b766-e063-6394a90a117f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "51407-208", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "30 mg/1"}], "application_number": "ANDA210918", "marketing_category": "ANDA", "marketing_start_date": "20181105", "listing_expiration_date": "20261231"}