FDA.reportPublic FDA data

Nitroglycerin

Product NDC
43478-410
11-digit product format
434780410
Labeler code
43478
Product ID
43478-410_905b7ddc-f00a-4303-9a62-8e4933bffc82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
AEROSOL, METERED
Route
SUBLINGUAL
Labeler
Rouses Point Pharm
Application
NDA021780
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-10-16
Marketing end
0000-00-00
Substance
NITROGLYCERIN
Active strength
400 ug/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43478-410-032022-01-28C16284748780-1d6a99b39-b6b5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Nitroglycerin Lingual Aerosol safely and effectively. See full prescribing information for Nitroglycerin Lingual Aerosol . Nitroglycerin Lingual Aerosol Initial U.S. Approval: 2006
43478-410-072022-01-28C16284748780-1d6a99b39-b6b5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Nitroglycerin Lingual Aerosol safely and effectively. See full prescribing information for Nitroglycerin Lingual Aerosol . Nitroglycerin Lingual Aerosol Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43478-410-03Nitroglycerin1 in 1 CARTONAEROSOL, METERED13
43478-410-03Nitroglycerin60 in 1 BOTTLEAEROSOL, METERED603
43478-410-07Nitroglycerin1 in 1 CARTONAEROSOL, METERED13
43478-410-07Nitroglycerin200 in 1 BOTTLEAEROSOL, METERED2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43478-410-03GM - Gram43478-41003c4714c-616b-4501-ae25-4526b6b7d83c12013-02-13
43478-410-07GM - Gram43478-410b2cfb3b8-dc6e-4213-a0a2-415e61eb1c3b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
BUTANEINACTIVE INGREDIENT6LV4FOR43RNITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDEINACTIVE INGREDIENTJ4BY50FL78NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43478-410NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]3Legacy NDC, 4 package rows20160923_3214ddac-e068-4306-8500-0fa90c8c5842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY3214ddac-e068-4306-8500-0fa90c8c58423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43478-410-03434780410031 BOTTLE in 1 CARTON (43478-410-03) > 60 AEROSOL, METERED in 1 BOTTLE1 bottle2012-10-160000-00-00NoNoCurrent
43478-410-07434780410071 BOTTLE in 1 CARTON (43478-410-07) > 200 AEROSOL, METERED in 1 BOTTLE1 bottle2012-10-160000-00-00NoNoCurrent