albuterol sulfate

Product NDC
53002-1552
11-digit product format
530021552
Labeler code
53002
Product ID
53002-1552_d62d54ac-71d4-4e36-aad9-e460f1fa9fce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA203760
Marketing category
ANDA
Marketing start
2020-02-26
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
021SEF3731ALBUTEROL SULFATE51022-70-9ALBUTEROL SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1552-1530021552011 INHALER in 1 CARTON (53002-1552-1) > 200 AEROSOL, METERED in 1 INHALER1 inhaler2020-02-260000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
albuterol sulfate - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL3