nitroglycerin lingual

Generic: nitroglycerin

Labeler: allegis pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin lingual
Generic Name nitroglycerin
Labeler allegis pharmaceuticals, llc
Dosage Form SPRAY
Routes
ORAL
Active Ingredients

nitroglycerin 400 ug/1

Manufacturer
Allegis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 28595-120
Product ID 28595-120_462b36d0-0a1e-bda8-e063-6294a90a5792
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA018705
Marketing Start 2019-07-01
Marketing End 2027-01-31

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 28595120
Hyphenated Format 28595-120

Supplemental Identifiers

RxCUI
705129
UPC
0328595120126
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 nitroglycerin lingual (source: ndc)
Generic Name nitroglycerin (source: ndc)
Application Number NDA018705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (28595-120-12) / 200 SPRAY in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (28595-120-49) / 60 SPRAY in 1 BOTTLE
source: ndc

Packages (2)

28595-120-12 1 BOTTLE in 1 CARTON (28595-120-12) / 200 SPRAY in 1 BOTTLE 28595-120-49 1 BOTTLE in 1 CARTON (28595-120-49) / 60 SPRAY in 1 BOTTLE

Ingredients (1)

nitroglycerin (400 ug/1)

Linked Drug Pages (1)

NITROGLYCERIN LINGUAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462b36d0-0a1e-bda8-e063-6294a90a5792", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0328595120126"], "unii": ["G59M7S0WS3"], "rxcui": ["705129"], "spl_set_id": ["fadd07b7-189b-4678-ad0f-bf1e4d3d1300"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Allegis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (28595-120-12)  / 200 SPRAY in 1 BOTTLE", "package_ndc": "28595-120-12", "marketing_end_date": "20260531", "marketing_start_date": "20190701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (28595-120-49)  / 60 SPRAY in 1 BOTTLE", "package_ndc": "28595-120-49", "marketing_end_date": "20270131", "marketing_start_date": "20190701"}], "brand_name": "NITROGLYCERIN LINGUAL", "product_id": "28595-120_462b36d0-0a1e-bda8-e063-6294a90a5792", "dosage_form": "SPRAY", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "28595-120", "generic_name": "Nitroglycerin", "labeler_name": "Allegis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROGLYCERIN LINGUAL", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "400 ug/1"}], "application_number": "NDA018705", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20270131", "marketing_start_date": "20190701"}