Albuterol Sulfate

Product NDC
68071-3902
11-digit product format
680713902
Labeler code
68071
Product ID
68071-3902_41201091-f162-bdc9-e063-6294a90a9c9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212447
Marketing category
ANDA
Marketing start
2024-08-06
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
68071-3902-2680713902021 INHALER in 1 CARTON (68071-3902-2) / 200 INHALANT in 1 INHALER1 inhaler2025-10-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2025-10-14HUMAN PRESCRIPTION DRUG LABEL1