Albuterol Sulfate

Product NDC
68788-4041
11-digit product format
687884041
Labeler code
68788
Product ID
68788-4041_081b7bbb-6692-4512-b135-863b73bf30a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212447
Marketing category
ANDA
Marketing start
2025-10-13
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
021SEF3731ALBUTEROL SULFATE51022-70-9ALBUTEROL SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4041-2687884041021 INHALER in 1 CARTON (68788-4041-2) / 200 INHALANT in 1 INHALER1 inhaler2025-10-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2025-10-13HUMAN PRESCRIPTION DRUG LABEL1