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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-142
Application NumberANDA209959
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 29, 2023
FDA Product Classification
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