isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler northwind health company, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 30 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-922
Product ID 51655-922_497428e5-d404-55ce-e063-6394a90ab8ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210918
Listing Expiration 2027-12-31
Marketing Start 2022-03-18

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 51655922
Hyphenated Format 51655-922

Supplemental Identifiers

RxCUI
317110
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
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-922-52)
source: ndc

Packages (1)

51655-922-52 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-922-52)

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": "497428e5-d404-55ce-e063-6394a90ab8ec", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["317110"], "spl_set_id": ["df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-922-52)", "package_ndc": "51655-922-52", "marketing_start_date": "20220318"}], "brand_name": "Isosorbide Mononitrate", "product_id": "51655-922_497428e5-d404-55ce-e063-6394a90ab8ec", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "51655-922", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Northwind Health Company, LLC", "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": "20220318", "listing_expiration_date": "20271231"}