FDA.reportPublic FDA data

VENTOLIN

Product NDC
52959-983
11-digit product format
529590983
Labeler code
52959
Product ID
52959-983_be7d9791-f676-426c-ba46-6dbaced723af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
H.J. Harkins Company, Inc.
Application
NDA020983
Marketing category
NDA
Marketing start
2006-06-09
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
108 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-983-082019-11-13C16284748780-197449f38-cc77-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use VENTOLIN HFA Inhalation Aerosol safely and effectively. See full prescribing information for VENTOLIN HFA Inhalation Aerosol. VENTOLIN ® HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981
52959-983-182019-11-13C16284748780-197449f38-cc77-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use VENTOLIN HFA Inhalation Aerosol safely and effectively. See full prescribing information for VENTOLIN HFA Inhalation Aerosol. VENTOLIN ® HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-983-08VENTOLINHFA60 in 1 INHALERAEROSOL, METERED603
52959-983-18VENTOLINHFA200 in 1 INHALERAEROSOL, METERED2003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]3
ALBUTEROLACTIVE MOIETYQF8SVZ843EVENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]3
NORFLURANEINACTIVE INGREDIENTDH9E53K1Y8VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-983VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 2 package rows20120123_77f24a8c-0a9a-4708-a401-3f56b5d4f2c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSN77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinPSN77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
859088Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801095Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
859088NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBD77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801095NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBD77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
2123076NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801092NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801092albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose InhalerSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801092albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
859088NDA020983 200 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose InhalerSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801095NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose InhalerSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801095Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
859088Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUATSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
859088Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801095Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13
801095Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY77f24a8c-0a9a-4708-a401-3f56b5d4f2c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-983-085295909830860 in 1 INHALERHistorical
52959-983-1852959098318200 in 1 INHALERHistorical