FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
68788-0825
11-digit product format
687880825
Labeler code
68788
Product ID
68788-0825_38ab392e-d9fb-4ea9-81de-eefbe75c4570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SYRUP
Route
ORAL
Labeler
Preferred Pharmaceuticals, inc
Application
ANDA074749
Marketing category
ANDA
Marketing start
2011-06-03
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct68788-0825DDiscontinued by firm2026-07-31
excluded packagepackage68788-082568788-0825-4DDiscontinued 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
A074749-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30

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 22:54:322026-06A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
SACCHARININACTIVE INGREDIENTFST467XS7DALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC]2