isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 60 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3081
Product ID 68071-3081_1d9c854f-2733-19f2-e063-6294a90aa15b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075522
Listing Expiration 2026-12-31
Marketing Start 2010-06-07

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 680713081
Hyphenated Format 68071-3081

Supplemental Identifiers

RxCUI
353538
UPC
0368071308136
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 ANDA075522 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-3)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-6)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-9)
source: ndc

Packages (3)

68071-3081-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-3) 68071-3081-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-6) 68071-3081-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-9)

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": "1d9c854f-2733-19f2-e063-6294a90aa15b", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0368071308136"], "unii": ["LX1OH63030"], "rxcui": ["353538"], "spl_set_id": ["4ab91ea4-3ddb-5fd3-e054-00144ff88e88"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-3)", "package_ndc": "68071-3081-3", "marketing_start_date": "20170314"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-6)", "package_ndc": "68071-3081-6", "marketing_start_date": "20170314"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-9)", "package_ndc": "68071-3081-9", "marketing_start_date": "20170314"}], "brand_name": "Isosorbide Mononitrate", "product_id": "68071-3081_1d9c854f-2733-19f2-e063-6294a90aa15b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "68071-3081", "generic_name": "Isosorbide Mononitrate", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "60 mg/1"}], "application_number": "ANDA075522", "marketing_category": "ANDA", "marketing_start_date": "20100607", "listing_expiration_date": "20261231"}