isosorbide

Generic: isosorbide dinitrate

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide
Generic Name isosorbide dinitrate
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 10 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-374
Product ID 68001-374_9498fa14-1614-4a8e-b872-41c11745b01e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086066
Listing Expiration 2026-12-31
Marketing Start 2018-11-30

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 68001374
Hyphenated Format 68001-374

Supplemental Identifiers

RxCUI
206842 314055 381056
UPC
0368001375009 0368001374002 0368001373005
UNII
IA7306519N
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 (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number ANDA086066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (68001-374-00)
source: ndc

Packages (1)

68001-374-00 100 TABLET in 1 BOTTLE, PLASTIC (68001-374-00)

Ingredients (1)

isosorbide dinitrate (10 mg/1)

Linked Drug Pages (1)

Isosorbide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9498fa14-1614-4a8e-b872-41c11745b01e", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0368001375009", "0368001374002", "0368001373005"], "unii": ["IA7306519N"], "rxcui": ["206842", "314055", "381056"], "spl_set_id": ["9498fa14-1614-4a8e-b872-41c11745b01e"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (68001-374-00)", "package_ndc": "68001-374-00", "marketing_start_date": "20181130"}], "brand_name": "Isosorbide", "product_id": "68001-374_9498fa14-1614-4a8e-b872-41c11745b01e", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "68001-374", "generic_name": "Isosorbide Dinitrate", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "10 mg/1"}], "application_number": "ANDA086066", "marketing_category": "ANDA", "marketing_start_date": "20181130", "listing_expiration_date": "20261231"}