nitrolingual

Generic: nitroglycerin

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

Drug Facts

Product Profile

Brand Name nitrolingual
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 28595-550
Product ID 28595-550_462b2d3f-67b1-c393-e063-6294a90a208a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018705
Marketing Start 2019-07-01
Marketing End 2026-05-31

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 28595550
Hyphenated Format 28595-550

Supplemental Identifiers

RxCUI
705129 995019
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 nitrolingual (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, SPRAY in 1 CARTON (28595-550-12) / 200 SPRAY in 1 BOTTLE, SPRAY
  • 1 BOTTLE, SPRAY in 1 CARTON (28595-550-49) / 60 SPRAY in 1 BOTTLE, SPRAY
source: ndc

Packages (2)

28595-550-12 1 BOTTLE, SPRAY in 1 CARTON (28595-550-12) / 200 SPRAY in 1 BOTTLE, SPRAY 28595-550-49 1 BOTTLE, SPRAY in 1 CARTON (28595-550-49) / 60 SPRAY in 1 BOTTLE, SPRAY

Ingredients (1)

nitroglycerin (400 ug/1)

Linked Drug Pages (1)

NITROLINGUAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462b2d3f-67b1-c393-e063-6294a90a208a", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["705129", "995019"], "spl_set_id": ["d8765f0e-1fe9-4e2a-9138-186c093edceb"], "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, SPRAY in 1 CARTON (28595-550-12)  / 200 SPRAY in 1 BOTTLE, SPRAY", "package_ndc": "28595-550-12", "marketing_end_date": "20260531", "marketing_start_date": "20190701"}, {"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (28595-550-49)  / 60 SPRAY in 1 BOTTLE, SPRAY", "package_ndc": "28595-550-49", "marketing_end_date": "20260531", "marketing_start_date": "20190701"}], "brand_name": "NITROLINGUAL", "product_id": "28595-550_462b2d3f-67b1-c393-e063-6294a90a208a", "dosage_form": "SPRAY", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "28595-550", "generic_name": "Nitroglycerin", "labeler_name": "Allegis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROLINGUAL", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "400 ug/1"}], "application_number": "NDA018705", "marketing_category": "NDA", "marketing_end_date": "20260531", "marketing_start_date": "20190701"}