Albuterol Sulfate

Product NDC
70518-4528
11-digit product format
705184528
Labeler code
70518
Product ID
70518-4528_450d43d4-5770-2263-e063-6294a90a583d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
NDA020503
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-12-03
Substance
ALBUTEROL SULFATE
Active strength
108 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
70518-4528-0705184528001 CANISTER in 1 CARTON (70518-4528-0) / 200 AEROSOL, METERED in 1 CANISTER1 canister2025-12-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate Inhalation Aerosol with Dose IndicatorREMEDYREPACK INC.2025-12-03HUMAN PRESCRIPTION DRUG LABEL1