Albuterol Sulfate

Product NDC
70518-4496
11-digit product format
705184496
Labeler code
70518
Product ID
70518-4496_40d02383-b4de-f95e-e063-6294a90afdea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA212447
Marketing category
ANDA
Marketing start
2025-10-10
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
70518-4496-0705184496001 INHALER in 1 CARTON (70518-4496-0) / 200 INHALANT in 1 INHALER1 inhaler2025-10-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate - REMEDYREPACK INC.REMEDYREPACK INC.2025-10-10HUMAN PRESCRIPTION DRUG LABEL1