FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
50090-0516
11-digit product format
500900516
Labeler code
50090
Product ID
50090-0516_6ece0588-777b-4260-acea-6f1f4d0fbdbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA077839
Marketing category
ANDA
Marketing start
2011-12-05
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
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 SULFATE2.5 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui630208

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
50090-0516-02023-02-07C16284748780-1f386c649-aac9-0266-e053-dadaa90a7c1aAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)
50090-0516-12023-02-07C16284748780-1f386c649-aac9-0266-e053-dadaa90a7c1aAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)
50090-0516-02023-01-30C16284748780-1f386c649-aac9-0266-e053-dadaa90a7c1aAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)
50090-0516-12023-01-30C16284748780-1f386c649-aac9-0266-e053-dadaa90a7c1aAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0516-0Albuterol Sulfate25 mL in 1 POUCHSOLUTION2522
50090-0516-0Albuterol Sulfate1 in 1 CARTONSOLUTION122
50090-0516-1Albuterol Sulfate25 mL in 1 POUCHSOLUTION2522
50090-0516-1Albuterol Sulfate5 in 1 CARTONSOLUTION522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0516-0ML - Milliliter50090-05166f44f69d-159e-4375-8605-c7df4993495b12018-08-13
50090-0516-1ML - Milliliter50090-05167f87548d-5420-4b1a-bfe4-d430806104a712018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0516ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS]22Current NDC, Legacy NDC, 4 package rows20240511_19867b61-77a2-46f1-97c7-7fadfec5882b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 0.83 MG/ML Inhalation SolutionSCD19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 0.083 % Inhalation SolutionSY19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY19867b61-77a2-46f1-97c7-7fadfec5882b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0516-0500900516001 POUCH in 1 CARTON (50090-0516-0) / 25 mL in 1 POUCH1 pouch2016-06-290000-00-00NoNoCurrent
50090-0516-1500900516015 POUCH in 1 CARTON (50090-0516-1) / 25 mL in 1 POUCH5 pouch2016-06-290000-00-00NoNoCurrent