isosorbide dinitrate

Generic: isosorbide dinitrate

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

Drug Facts

Product Profile

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

isosorbide dinitrate 30 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-562
Product ID 68001-562_224fb831-928b-b275-e063-6394a90ab649
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213057
Listing Expiration 2026-12-31
Marketing Start 2023-08-05

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 68001562
Hyphenated Format 68001-562

Supplemental Identifiers

RxCUI
197839
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 dinitrate (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number ANDA213057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68001-562-00)
source: ndc

Packages (1)

68001-562-00 100 TABLET in 1 BOTTLE (68001-562-00)

Ingredients (1)

isosorbide dinitrate (30 mg/1)

Linked Drug Pages (1)

Isosorbide dinitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "224fb831-928b-b275-e063-6394a90ab649", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["197839"], "spl_set_id": ["f1d52e9a-8de1-61db-e053-2a95a90aae50"], "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 (68001-562-00)", "package_ndc": "68001-562-00", "marketing_start_date": "20230805"}], "brand_name": "Isosorbide dinitrate", "product_id": "68001-562_224fb831-928b-b275-e063-6394a90ab649", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "68001-562", "generic_name": "Isosorbide dinitrate", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "30 mg/1"}], "application_number": "ANDA213057", "marketing_category": "ANDA", "marketing_start_date": "20230805", "listing_expiration_date": "20261231"}