nitroglycerin lingual

Generic: nitroglycerin

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin lingual
Generic Name nitroglycerin
Labeler padagis israel pharmaceuticals ltd
Dosage Form SPRAY
Routes
ORAL
Active Ingredients

nitroglycerin 400 ug/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-210
Product ID 45802-210_e75425f2-a532-4b73-9b24-258a7dcc34b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091496
Listing Expiration 2026-12-31
Marketing Start 2013-09-20

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 45802210
Hyphenated Format 45802-210

Supplemental Identifiers

RxCUI
705129
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 ANDA091496 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (45802-210-02) / 200 SPRAY in 1 BOTTLE
source: ndc

Packages (2)

45802-210-01 1 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLE 45802-210-02 1 BOTTLE in 1 CARTON (45802-210-02) / 200 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": "e75425f2-a532-4b73-9b24-258a7dcc34b9", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["705129"], "spl_set_id": ["e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-210-01)  / 60 SPRAY in 1 BOTTLE", "package_ndc": "45802-210-01", "marketing_start_date": "20130920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-210-02)  / 200 SPRAY in 1 BOTTLE", "package_ndc": "45802-210-02", "marketing_start_date": "20130920"}], "brand_name": "nitroglycerin lingual", "product_id": "45802-210_e75425f2-a532-4b73-9b24-258a7dcc34b9", "dosage_form": "SPRAY", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "45802-210", "generic_name": "Nitroglycerin", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitroglycerin lingual", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "400 ug/1"}], "application_number": "ANDA091496", "marketing_category": "ANDA", "marketing_start_date": "20130920", "listing_expiration_date": "20261231"}