Albuterol Sulfate

Product NDC
76420-531
11-digit product format
764200531
Labeler code
76420
Product ID
76420-531_f104fd15-0d76-3db4-e053-2995a90a1a88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Asclemed USA, Inc.
Application
ANDA207085
Marketing category
ANDA
Marketing start
2021-11-30
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 formatDescriptionMarketing startSampleExclude flagStatus
76420-531-0176420053101200 AEROSOL, METERED in 1 CANISTER (76420-531-01) 2022-12-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate Inhalation Aerosol with Dose IndicatorAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2022-12-13HUMAN PRESCRIPTION DRUG LABEL1