FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
50090-0517
11-digit product format
500900517
Labeler code
50090
Product ID
50090-0517_828699f9-ab4e-4f80-960d-60d0d786ffc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA074543
Marketing category
ANDA
Marketing start
1998-01-15
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0517DDiscontinued by firm2026-07-31
excluded packagepackage50090-051750090-0517-0DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074543-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.5% BASESOLUTION / INHALATIONAN1998-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074543-001AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074543-001ALBUTEROL SULFATEEQ 0.5% BASESOLUTION / INHALATIONAN1998-01-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074543-001AN1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0517-02023-02-07C16284748780-1f386c649-e8f8-0266-e053-dadaa90a7c1aALBUTEROL SULFATE INHALATION SOLUTION, 0.5%* STERILE (*Potency expressed as albuterol)
50090-0517-02023-01-30C16284748780-1f386c649-e8f8-0266-e053-dadaa90a7c1aALBUTEROL SULFATE INHALATION SOLUTION, 0.5%* STERILE (*Potency expressed as albuterol)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0517-0ML - Milliliter50090-05172311cd26-2c88-43bb-894c-96a1cae5aaeb12018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0517-0500900517001 BOTTLE, GLASS in 1 CARTON (50090-0517-0) > 20 mL in 1 BOTTLE, GLASS2016-06-290000-00-00NoNoCurrent