FDA.reportPublic FDA data

ALBUTEROL SULFATE

Product NDC
51662-1267
11-digit product format
516621267
Labeler code
51662
Product ID
51662-1267_1203bab9-5b5e-fb79-e063-6394a90a48ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA020983
Marketing category
NDA
Marketing start
2018-09-22
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
ALBUTEROL SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE90 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui801092

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
51662-1267-12020-02-07C16284748780-19d75b9d0-3793-f424-e053-dadaa90a57ceVENTOLIN® HFA (ALBUTEROL SULFATE) 90mcg
51662-1267-92020-02-07C16284748780-19d75b9d0-3793-f424-e053-dadaa90a57ceVENTOLIN® HFA (ALBUTEROL SULFATE) 90mcg
51662-1267-12020-01-31C16284748780-19d75b9d0-3793-f424-e053-dadaa90a57ceVENTOLIN® HFA (ALBUTEROL SULFATE) 90mcg
51662-1267-92020-01-31C16284748780-19d75b9d0-3793-f424-e053-dadaa90a57ceVENTOLIN® HFA (ALBUTEROL SULFATE) 90mcg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1267-1ALBUTEROL SULFATE60 in 1 INHALERAEROSOL, METERED609
51662-1267-1ALBUTEROL SULFATE1 in 1 CARTONAEROSOL, METERED19
51662-1267-9ALBUTEROL SULFATE60 in 1 INHALERAEROSOL, METERED609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1267ALBUTEROL SULFATE AEROSOL, METERED [HF ACQUISITION CO LLC, DBA HEALTHFIRST]9Current NDC, Legacy NDC, 3 package rows20240224_767a1504-1e04-1e06-e053-2a91aa0aa4b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinPSN767a1504-1e04-1e06-e053-2a91aa0aa4b69
801092NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD767a1504-1e04-1e06-e053-2a91aa0aa4b69
801092albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose InhalerSY767a1504-1e04-1e06-e053-2a91aa0aa4b69
801092albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY767a1504-1e04-1e06-e053-2a91aa0aa4b69
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinSY767a1504-1e04-1e06-e053-2a91aa0aa4b69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1267-1516621267011 INHALER in 1 CARTON (51662-1267-1) / 60 AEROSOL, METERED in 1 INHALER1 inhaler2018-09-220000-00-00NoNoCurrent
51662-1267-95166212670960 AEROSOL, METERED in 1 INHALER (51662-1267-9) 2018-09-220000-00-00NoNoCurrent