ALBUTEROL SULFATE

Product NDC
71335-2907
11-digit product format
713352907
Labeler code
71335
Product ID
71335-2907_474dd04b-2935-4af1-a309-958c00f08193
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SYRUP
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212197
Marketing category
ANDA
Marketing start
2019-09-06
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
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
71335-2907-171335290701473 mL in 1 BOTTLE (71335-2907-1) 473 ml2025-11-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate Syrup, 2 mg/5 mL Rx onlyBryant Ranch Prepack2025-11-10HUMAN PRESCRIPTION DRUG LABEL100