FDA.reportPublic FDA data

VENTOLIN

Product NDC
68071-1890
11-digit product format
680711890
Labeler code
68071
Product ID
68071-1890_1d601217-df1a-44bc-e063-6394a90a8418
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1890-62023-02-10C16284748780-1f386c64a-002f-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 Initial U.S. Approval: 1981
68071-1890-62023-01-30C16284748780-1f386c64a-002f-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 Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1890-6VENTOLINHFA60 in 1 BOXAEROSOL, METERED607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1890VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240717_7043bc12-8a58-8ff8-e053-2a91aa0ab627.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinPSN7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801095Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801095NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBD7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801092NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801092albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose InhalerSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801092albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801095NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose InhalerSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801095Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801095Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277
801095Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY7043bc12-8a58-8ff8-e053-2a91aa0ab6277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-1890-66807118900660 AEROSOL, METERED in 1 BOX (68071-1890-6) 2018-07-050000-00-00NoNoCurrent