isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler chartwell rx, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 120 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-588
Product ID 62135-588_44fde4f9-0086-6476-e063-6394a90a6a92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210822
Listing Expiration 2026-12-31
Marketing Start 2018-11-15

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 62135588
Hyphenated Format 62135-588

Supplemental Identifiers

RxCUI
311196 317110 353538
UPC
0362135586904 0362135588908 0362135587901
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 ANDA210822 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-588-90)
source: ndc

Packages (1)

62135-588-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-588-90)

Ingredients (1)

isosorbide mononitrate (120 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": "44fde4f9-0086-6476-e063-6394a90a6a92", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0362135586904", "0362135588908", "0362135587901"], "unii": ["LX1OH63030"], "rxcui": ["311196", "317110", "353538"], "spl_set_id": ["b38f43c8-d02d-4aee-ab23-e898cbfadfbc"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-588-90)", "package_ndc": "62135-588-90", "marketing_start_date": "20230426"}], "brand_name": "Isosorbide Mononitrate", "product_id": "62135-588_44fde4f9-0086-6476-e063-6394a90a6a92", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "62135-588", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "120 mg/1"}], "application_number": "ANDA210822", "marketing_category": "ANDA", "marketing_start_date": "20181115", "listing_expiration_date": "20261231"}