isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler cardinal health 107, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 30 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-7291
Product ID 55154-7291_92197742-097e-45e9-991c-4ec077e3b507
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200270
Listing Expiration 2026-12-31
Marketing Start 2015-01-05

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 551547291
Hyphenated Format 55154-7291

Supplemental Identifiers

RxCUI
317110 353538
UPC
0055154729208 0055154729109
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 ANDA200270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-7291-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

55154-7291-0 10 BLISTER PACK in 1 BAG (55154-7291-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "92197742-097e-45e9-991c-4ec077e3b507", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0055154729208", "0055154729109"], "unii": ["LX1OH63030"], "rxcui": ["317110", "353538"], "spl_set_id": ["72b8a20c-5833-4765-a4b5-9066eaec6ea1"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-7291-0)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55154-7291-0", "marketing_start_date": "20150105"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "55154-7291_92197742-097e-45e9-991c-4ec077e3b507", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "55154-7291", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE MONONITRATE", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "30 mg/1"}], "application_number": "ANDA200270", "marketing_category": "ANDA", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}