ALBUTEROL SULFATE
ALBUTEROL SULFATE Inhalation Aerosol, with Dose Indicator FOR ORAL INHALATION ONLY Prescribing Information
Approved
Approval ID
c4d6d76a-14b8-411a-8019-e2c923c2c532
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 29, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
albuterol sulfate
PRODUCT DETAILS
NDC Product Code69097-142
Application NumberANDA209959
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 29, 2023
Generic Namealbuterol sulfate
INGREDIENTS (4)
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT