isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

isosorbide dinitrate 20 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-449
Product ID 50268-449_4a7f77ca-73e0-4162-e063-6294a90a1418
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087537
Listing Expiration 2027-12-31
Marketing Start 2016-09-13

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 50268449
Hyphenated Format 50268-449

Supplemental Identifiers

RxCUI
206842 314055 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 ANDA087537 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-449-15) / 1 TABLET in 1 BLISTER PACK (50268-449-11)
source: ndc

Packages (1)

50268-449-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-449-15) / 1 TABLET in 1 BLISTER PACK (50268-449-11)

Ingredients (1)

isosorbide dinitrate (20 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": "4a7f77ca-73e0-4162-e063-6294a90a1418", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["206842", "314055", "381056"], "spl_set_id": ["0e5842f2-74f6-1f02-01bc-07578bd3b393"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-449-15)  / 1 TABLET in 1 BLISTER PACK (50268-449-11)", "package_ndc": "50268-449-15", "marketing_start_date": "20160913"}], "brand_name": "Isosorbide Dinitrate", "product_id": "50268-449_4a7f77ca-73e0-4162-e063-6294a90a1418", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "50268-449", "generic_name": "isosorbide dinitrate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "ANDA087537", "marketing_category": "ANDA", "marketing_start_date": "20160913", "listing_expiration_date": "20271231"}