isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 5 mg/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-007
Product ID 16714-007_be0de7ff-f8d9-472f-a35c-252a2cf16954
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213057
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

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 16714007
Hyphenated Format 16714-007

Supplemental Identifiers

RxCUI
197839 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
  • 100 TABLET in 1 BOTTLE (16714-007-01)
source: ndc

Packages (1)

16714-007-01 100 TABLET in 1 BOTTLE (16714-007-01)

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": "be0de7ff-f8d9-472f-a35c-252a2cf16954", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["197839", "206842", "314055", "381056"], "spl_set_id": ["246c749d-aa28-44ce-8d42-984660afff2a"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16714-007-01)", "package_ndc": "16714-007-01", "marketing_start_date": "20200501"}], "brand_name": "Isosorbide dinitrate", "product_id": "16714-007_be0de7ff-f8d9-472f-a35c-252a2cf16954", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "16714-007", "generic_name": "Isosorbide dinitrate", "labeler_name": "Northstar Rx LLC", "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": "20200501", "listing_expiration_date": "20261231"}