isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3637
Product ID 70518-3637_3f1991fb-9ad0-8acc-e063-6394a90a0e39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213057
Listing Expiration 2026-12-31
Marketing Start 2023-02-09

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 705183637
Hyphenated Format 70518-3637

Supplemental Identifiers

RxCUI
381056
UNII
IA7306519N
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 dinitrate (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number ANDA213057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3637-0)
source: ndc

Packages (1)

70518-3637-0 30 TABLET in 1 BLISTER PACK (70518-3637-0)

Ingredients (1)

isosorbide dinitrate (10 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": "3f1991fb-9ad0-8acc-e063-6394a90a0e39", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["381056"], "spl_set_id": ["9d2f284a-38bc-4a4b-aa77-c37812998739"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3637-0)", "package_ndc": "70518-3637-0", "marketing_start_date": "20230209"}], "brand_name": "Isosorbide dinitrate", "product_id": "70518-3637_3f1991fb-9ad0-8acc-e063-6394a90a0e39", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "70518-3637", "generic_name": "Isosorbide dinitrate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "10 mg/1"}], "application_number": "ANDA213057", "marketing_category": "ANDA", "marketing_start_date": "20230209", "listing_expiration_date": "20261231"}