isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 60 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-7768
Product ID 0615-7768_4beb800d-fb92-42eb-a765-50ed0dfe1587
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200495
Listing Expiration 2026-12-31
Marketing Start 2011-06-03

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 06157768
Hyphenated Format 0615-7768

Supplemental Identifiers

RxCUI
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 ANDA200495 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39)
source: ndc

Packages (2)

0615-7768-05 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05) 0615-7768-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39)

Ingredients (1)

isosorbide mononitrate (60 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": "4beb800d-fb92-42eb-a765-50ed0dfe1587", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["353538"], "spl_set_id": ["ba6120c8-c885-4cfa-b68e-9eee7a3bad6d"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05)", "package_ndc": "0615-7768-05", "marketing_start_date": "20220203"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39)", "package_ndc": "0615-7768-39", "marketing_start_date": "20220203"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "0615-7768_4beb800d-fb92-42eb-a765-50ed0dfe1587", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0615-7768", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE MONONITRATE", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "60 mg/1"}], "application_number": "ANDA200495", "marketing_category": "ANDA", "marketing_start_date": "20110603", "listing_expiration_date": "20261231"}