FDA.reportPublic FDA data

ALBUTEROL SULFATE

Product NDC
50090-5179
11-digit product format
500905179
Labeler code
50090
Product ID
50090-5179_f40dcc5d-0c31-451a-8cf2-ab083228c155
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA209959
Marketing category
ANDA
Marketing start
2020-04-08
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
Rxcui2123111

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
50090-5179-02024-01-29C16284748780-1f386c64a-42f5-0266-e053-dadaa90a7c1aALBUTEROL SULFATE Inhalation Aerosol, with Dose Indicator FOR ORAL INHALATION ONLY Prescribing Information
50090-5179-12024-01-29C16284748780-1f386c64a-42f5-0266-e053-dadaa90a7c1aALBUTEROL SULFATE Inhalation Aerosol, with Dose Indicator FOR ORAL INHALATION ONLY Prescribing Information
50090-5179-02023-01-30C16284748780-1f386c64a-42f5-0266-e053-dadaa90a7c1aALBUTEROL SULFATE Inhalation Aerosol, with Dose Indicator FOR ORAL INHALATION ONLY Prescribing Information
50090-5179-12023-01-30C16284748780-1f386c64a-42f5-0266-e053-dadaa90a7c1aALBUTEROL SULFATE Inhalation Aerosol, with Dose Indicator FOR ORAL INHALATION ONLY Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5179-0ALBUTEROL SULFATE200 in 1 CANISTERINHALANT2008
50090-5179-0ALBUTEROL SULFATE1 in 1 CARTONINHALANT18
50090-5179-1ALBUTEROL SULFATE144 in 1 CASEINHALANT1448
50090-5179-1ALBUTEROL SULFATE200 in 1 CANISTERINHALANT2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5179ALBUTEROL SULFATE INHALANT [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 4 package rows20240129_a9188951-3711-412c-89c6-e8db784dcb65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNa9188951-3711-412c-89c6-e8db784dcb658
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDa9188951-3711-412c-89c6-e8db784dcb658
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYa9188951-3711-412c-89c6-e8db784dcb658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5179-0500905179001 CANISTER in 1 CARTON (50090-5179-0) / 200 INHALANT in 1 CANISTER1 canister2020-09-280000-00-00NoNoCurrent
50090-5179-150090517901144 CANISTER in 1 CASE (50090-5179-1) / 200 INHALANT in 1 CANISTER144 canister2020-10-060000-00-00NoNoCurrent