ALBUTEROL SULFATE

Product NDC
68788-7573
11-digit product format
687887573
Labeler code
68788
Product ID
68788-7573_e9b207d7-0c31-45ac-a0ab-8d5b96ffd983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SYRUP
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212197
Marketing category
ANDA
Marketing start
2020-05-01
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
68788-7573-468788757304473 mL in 1 BOTTLE (68788-7573-4) 473 ml2020-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate Syrup, 2 mg/5 mL Rx onlyPreferred Pharmaceuticals, Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL6