FDA.reportPublic FDA data

VENTOLIN

Product NDC
70518-1237
11-digit product format
705181237
Labeler code
70518
Product ID
70518-1237_36eac8d9-4b4a-6d44-e063-6394a90aae10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
NDA020983
Marketing category
NDA
Marketing start
2018-05-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VENTOLIN
Brand name suffix
HFA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE90 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui801092, 801095

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1237-0VENTOLINHFA60 in 1 INHALERAEROSOL, METERED6013
70518-1237-0VENTOLINHFA1 in 1 CARTONAEROSOL, METERED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1237VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 2 package rows20250509_2ed73618-be3a-4331-9509-6401258f791f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinPSN2ed73618-be3a-4331-9509-6401258f791f13
801095Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN2ed73618-be3a-4331-9509-6401258f791f13
801095NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBD2ed73618-be3a-4331-9509-6401258f791f13
801092NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD2ed73618-be3a-4331-9509-6401258f791f13
801092albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose InhalerSY2ed73618-be3a-4331-9509-6401258f791f13
801092albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY2ed73618-be3a-4331-9509-6401258f791f13
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinSY2ed73618-be3a-4331-9509-6401258f791f13
801095NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose InhalerSY2ed73618-be3a-4331-9509-6401258f791f13
801095Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY2ed73618-be3a-4331-9509-6401258f791f13
801095Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY2ed73618-be3a-4331-9509-6401258f791f13
801095Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY2ed73618-be3a-4331-9509-6401258f791f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1237-0705181237001 INHALER in 1 CARTON (70518-1237-0) / 60 AEROSOL, METERED in 1 INHALER1 inhaler2018-05-300000-00-00NoNoCurrent