FDA.reportPublic FDA data

VENTOLIN HFA

Product NDC
72189-016
11-digit product format
721890016
Labeler code
72189
Product ID
72189-016_a8497acf-b1ce-0a3b-e053-2995a90a870b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
DIRECT RX
Application
NDA020983
Marketing category
NDA
Marketing start
2020-06-17
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
90 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
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
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
72189-016-082023-01-30C16284748780-1f386c64a-030f-0266-e053-dadaa90a7c1aVENTOLIN HFA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-016-08VENTOLIN HFA90 in 1 BOTTLEAEROSOL, METERED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-016VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [DIRECT RX]1Legacy NDC, 1 package rows20200618_a8497acf-b1cd-0a3b-e053-2995a90a870b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinPSNa8497acf-b1cd-0a3b-e053-2995a90a870b1
801095Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNa8497acf-b1cd-0a3b-e053-2995a90a870b1
801095NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBDa8497acf-b1cd-0a3b-e053-2995a90a870b1
801092NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDa8497acf-b1cd-0a3b-e053-2995a90a870b1
801092albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose InhalerSYa8497acf-b1cd-0a3b-e053-2995a90a870b1
801092albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSYa8497acf-b1cd-0a3b-e053-2995a90a870b1
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinSYa8497acf-b1cd-0a3b-e053-2995a90a870b1
801095NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose InhalerSYa8497acf-b1cd-0a3b-e053-2995a90a870b1
801095Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSYa8497acf-b1cd-0a3b-e053-2995a90a870b1
801095Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSYa8497acf-b1cd-0a3b-e053-2995a90a870b1
801095Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSYa8497acf-b1cd-0a3b-e053-2995a90a870b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-016-087218900160890 AEROSOL, METERED in 1 BOTTLE (72189-016-08) 2020-06-170000-00-00NoNoCurrent