FDA.reportPublic FDA data

VENTOLIN

Product NDC
50090-1159
11-digit product format
500901159
Labeler code
50090
Product ID
50090-1159_a9add8b2-769a-4bcb-9356-54eadb16a2df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA020983
Marketing category
NDA
Marketing start
2006-06-09
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
Rxcui859088, 2123076

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
50090-1159-02023-02-07C16284748780-1f386c64a-3dcf-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate inhalation aerosol), for oral inhalation use Initial U.S. Approval: 1981
50090-1159-02023-01-30C16284748780-1f386c64a-3dcf-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate inhalation aerosol), for oral inhalation use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1159-0VENTOLINHFA1 in 1 CARTONAEROSOL, METERED117
50090-1159-0VENTOLINHFA200 in 1 INHALERAEROSOL, METERED20017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1159-0GM - Gram50090-1159db90645c-bc16-49dc-9b4e-f8ada4bce31d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1159VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 2 package rows20240608_aff836e4-34f2-4ab9-bbf8-0c41ac848cb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSNaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
859088Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
859088NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBDaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
2123076NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinSYaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
859088NDA020983 200 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose InhalerSYaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
859088Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUATSYaff836e4-34f2-4ab9-bbf8-0c41ac848cb017
859088Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYaff836e4-34f2-4ab9-bbf8-0c41ac848cb017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1159-0500901159001 INHALER in 1 CARTON (50090-1159-0) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2014-11-280000-00-00NoNoCurrent