isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 30 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-104
Product ID 13668-104_c7ad5562-be58-45d3-ae31-5dfa0d6a6c81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200270
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 13668104
Hyphenated Format 13668-104

Supplemental Identifiers

RxCUI
311196 317110 353538
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 ANDA200270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-10)
source: ndc

Packages (3)

13668-104-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-01) 13668-104-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-05) 13668-104-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-10)

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": "c7ad5562-be58-45d3-ae31-5dfa0d6a6c81", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["311196", "317110", "353538"], "spl_set_id": ["0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-01)", "package_ndc": "13668-104-01", "marketing_start_date": "20110603"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-05)", "package_ndc": "13668-104-05", "marketing_start_date": "20240823"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-10)", "package_ndc": "13668-104-10", "marketing_start_date": "20110603"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "13668-104_c7ad5562-be58-45d3-ae31-5dfa0d6a6c81", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "13668-104", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "Torrent Pharmaceuticals Limited", "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": "20110603", "listing_expiration_date": "20261231"}