FDA.reportPublic FDA data

NitroMist

Product NDC
73262-430
11-digit product format
732620430
Labeler code
73262
Product ID
73262-430_a73e2d71-97fa-0596-e053-2a95a90a0951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
AEROSOL, METERED
Route
SUBLINGUAL
Labeler
Evus Pharmaceuticals, LLC
Application
NDA021780
Marketing category
NDA
Marketing start
2016-01-25
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
2021-12-31
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
73262-430-042022-01-28C16284748780-1d6a99b39-73dc-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use NitroMist safely and effectively. See full prescribing information for NitroMist. NitroMist® (nitroglycerin) lingual aerosol Initial U.S. Approval: 2006
73262-430-082022-01-28C16284748780-1d6a99b39-73dc-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use NitroMist safely and effectively. See full prescribing information for NitroMist. NitroMist® (nitroglycerin) lingual aerosol Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73262-430-04NitroMist1 in 1 CARTONAEROSOL, METERED14
73262-430-04NitroMist90 in 1 BOTTLEAEROSOL, METERED904
73262-430-08NitroMist230 in 1 BOTTLEAEROSOL, METERED2304
73262-430-08NitroMist1 in 1 CARTONAEROSOL, METERED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73262-430NITROMIST (NITROGLYCERIN) AEROSOL, METERED [EVUS PHARMACEUTICALS, LLC]4Legacy NDC, 4 package rows20200609_db97f3b9-6608-482f-a0ef-ad1cf610e520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSNdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705133NitroMist 400 MCG/ACTUAT Mucosal SprayPSNdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705133nitroglycerin 0.4 MG/ACTUAT Mucosal Spray [NitroMist]SBDdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCDdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705133NitroMist 0.4 MG/ACTUAT Mucosal SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705133NitroMist 400 MCG/ACTUAT Mucosal SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705129NTG 0.4 MG/ACTUAT Mucosal SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705133NTG 0.4 MG/ACTUAT Mucosal Spray [NitroMist]SYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705129TNG 0.4 MG/ACTUAT Mucosal SpraySYdb97f3b9-6608-482f-a0ef-ad1cf610e5204
705133TNG 0.4 MG/ACTUAT Mucosal Spray [NitroMist]SYdb97f3b9-6608-482f-a0ef-ad1cf610e5204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73262-430-04732620430041 BOTTLE in 1 CARTON (73262-430-04) > 90 AEROSOL, METERED in 1 BOTTLE1 bottle2016-01-250000-00-00NoNoCurrent
73262-430-08732620430081 BOTTLE in 1 CARTON (73262-430-08) > 230 AEROSOL, METERED in 1 BOTTLE1 bottle2016-01-250000-00-00NoNoCurrent