nitro-dur

Generic: nitroglycerin

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitro-dur
Generic Name nitroglycerin
Labeler ingenus pharmaceuticals, llc
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

nitroglycerin 160 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-518
Product ID 50742-518_fcec90fc-83c9-15e2-e053-6394a90ab2d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020145
Listing Expiration 2026-12-31
Marketing Start 2017-12-06

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 50742518
Hyphenated Format 50742-518

Supplemental Identifiers

RxCUI
486146 486148 486152 861657 899521 899607 899642 899660 899688 899690 899703 899705
UNII
G59M7S0WS3
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 nitro-dur (source: ndc)
Generic Name nitroglycerin (source: ndc)
Application Number NDA020145 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX, UNIT-DOSE (50742-518-30) / 1 PATCH in 1 POUCH
source: ndc

Packages (1)

50742-518-30 30 POUCH in 1 BOX, UNIT-DOSE (50742-518-30) / 1 PATCH in 1 POUCH

Ingredients (1)

nitroglycerin (160 mg/1)

Linked Drug Pages (1)

NITRO-DUR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "fcec90fc-83c9-15e2-e053-6394a90ab2d5", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["486146", "486148", "486152", "861657", "899521", "899607", "899642", "899660", "899688", "899690", "899703", "899705"], "spl_set_id": ["5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX, UNIT-DOSE (50742-518-30)  / 1 PATCH in 1 POUCH", "package_ndc": "50742-518-30", "marketing_start_date": "20171206"}], "brand_name": "NITRO-DUR", "product_id": "50742-518_fcec90fc-83c9-15e2-e053-6394a90ab2d5", "dosage_form": "PATCH", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "50742-518", "generic_name": "nitroglycerin", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITRO-DUR", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "160 mg/1"}], "application_number": "NDA020145", "marketing_category": "NDA", "marketing_start_date": "20171206", "listing_expiration_date": "20261231"}