isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-772
Product ID 71610-772_10f2e7b3-b561-443d-9bfd-6c3420a9edb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210918
Listing Expiration 2026-12-31
Marketing Start 2018-11-05

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 71610772
Hyphenated Format 71610-772

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
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-30)
  • 45 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-45)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-60)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-80)
source: ndc

Packages (4)

71610-772-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-30) 71610-772-45 45 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-45) 71610-772-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-60) 71610-772-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-80)

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": "10f2e7b3-b561-443d-9bfd-6c3420a9edb7", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["353538"], "spl_set_id": ["0af6c67f-919d-4515-8074-f6c3aaa835b5"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-30)", "package_ndc": "71610-772-30", "marketing_start_date": "20240122"}, {"sample": false, "description": "45 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-45)", "package_ndc": "71610-772-45", "marketing_start_date": "20240122"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-60)", "package_ndc": "71610-772-60", "marketing_start_date": "20240125"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-772-80)", "package_ndc": "71610-772-80", "marketing_start_date": "20240122"}], "brand_name": "Isosorbide Mononitrate", "product_id": "71610-772_10f2e7b3-b561-443d-9bfd-6c3420a9edb7", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "71610-772", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20181105", "listing_expiration_date": "20261231"}