isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1501
Product ID 70771-1501_3b64c3fa-5b13-4c53-96e1-221685297680
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213057
Listing Expiration 2026-12-31
Marketing Start 2019-11-25

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 707711501
Hyphenated Format 70771-1501

Supplemental Identifiers

RxCUI
197839 197840 206842 314055 381056
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
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1501-0)
  • 100 TABLET in 1 BOTTLE (70771-1501-1)
source: ndc

Packages (2)

70771-1501-0 1000 TABLET in 1 BOTTLE (70771-1501-0) 70771-1501-1 100 TABLET in 1 BOTTLE (70771-1501-1)

Ingredients (1)

isosorbide dinitrate (5 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": "3b64c3fa-5b13-4c53-96e1-221685297680", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["197839", "197840", "206842", "314055", "381056"], "spl_set_id": ["5b0db8af-bcf9-458f-b752-420130cba428"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1501-0)", "package_ndc": "70771-1501-0", "marketing_start_date": "20191125"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1501-1)", "package_ndc": "70771-1501-1", "marketing_start_date": "20191125"}], "brand_name": "Isosorbide dinitrate", "product_id": "70771-1501_3b64c3fa-5b13-4c53-96e1-221685297680", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "70771-1501", "generic_name": "Isosorbide dinitrate", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "5 mg/1"}], "application_number": "ANDA213057", "marketing_category": "ANDA", "marketing_start_date": "20191125", "listing_expiration_date": "20261231"}