isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 30 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1151
Product ID 70710-1151_60a0c153-add8-44d9-a2f1-4c333d0eb42d
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 707101151
Hyphenated Format 70710-1151

Supplemental Identifiers

RxCUI
197839 197840 206842 314055 381056
UPC
0370710114916
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
  • 1000 TABLET in 1 BOTTLE (70710-1151-0)
  • 100 TABLET in 1 BOTTLE (70710-1151-1)
source: ndc

Packages (2)

70710-1151-0 1000 TABLET in 1 BOTTLE (70710-1151-0) 70710-1151-1 100 TABLET in 1 BOTTLE (70710-1151-1)

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": "60a0c153-add8-44d9-a2f1-4c333d0eb42d", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0370710114916"], "unii": ["IA7306519N"], "rxcui": ["197839", "197840", "206842", "314055", "381056"], "spl_set_id": ["16818b32-ee5e-4e07-b848-31e892c4b98a"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70710-1151-0)", "package_ndc": "70710-1151-0", "marketing_start_date": "20191125"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70710-1151-1)", "package_ndc": "70710-1151-1", "marketing_start_date": "20191125"}], "brand_name": "Isosorbide dinitrate", "product_id": "70710-1151_60a0c153-add8-44d9-a2f1-4c333d0eb42d", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "70710-1151", "generic_name": "Isosorbide dinitrate", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "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": "20191125", "listing_expiration_date": "20261231"}