Albuterol Sulfate
Albuterol Sulfate Inhalation Solution 0.083%* (*Potency expressed as albuterol) PRESCRIBING INFORMATION FOR INHALATION USE ONLY–NOT FOR INJECTION.
Approved
Approval ID
5de6a189-a8b7-4b33-b162-add6b6e4b275
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8492
Application NumberANDA207857
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJuly 24, 2023
FDA Product Classification
INGREDIENTS (6)
ALBUTEROL SULFATEActive
Quantity: 0.83 mg in 1 mL
Code: 021SEF3731
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT