isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 60 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2192
Product ID 71335-2192_79752f3a-c401-46d7-84a5-9383a04c792d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210918
Listing Expiration 2026-12-31
Marketing Start 2018-11-13

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 713352192
Hyphenated Format 71335-2192

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 ANDA210918 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-2)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-3)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-4)
  • 10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-5)
source: ndc

Packages (5)

71335-2192-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-1) 71335-2192-2 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-2) 71335-2192-3 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-3) 71335-2192-4 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-4) 71335-2192-5 10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-5)

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": "79752f3a-c401-46d7-84a5-9383a04c792d", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["353538"], "spl_set_id": ["96420729-2bc7-4d03-9c51-f786ea678998"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-1)", "package_ndc": "71335-2192-1", "marketing_start_date": "20221201"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-2)", "package_ndc": "71335-2192-2", "marketing_start_date": "20221201"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-3)", "package_ndc": "71335-2192-3", "marketing_start_date": "20221201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-4)", "package_ndc": "71335-2192-4", "marketing_start_date": "20221201"}, {"sample": false, "description": "10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-5)", "package_ndc": "71335-2192-5", "marketing_start_date": "20221201"}], "brand_name": "Isosorbide Mononitrate", "product_id": "71335-2192_79752f3a-c401-46d7-84a5-9383a04c792d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "71335-2192", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "60 mg/1"}], "application_number": "ANDA210918", "marketing_category": "ANDA", "marketing_start_date": "20181113", "listing_expiration_date": "20261231"}