Albuterol Sulfate
Albuterol Inhalation Solution, USP 0.083% PRESCRIBING INFORMATION FOR INHALATION USE ONLY–NOT FOR INJECTION.
Approved
Approval ID
bb538b7d-e390-419a-9404-a57c1db4a447
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code47335-703
Application NumberANDA207857
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 0.83 mg in 1 mL
Code: 021SEF3731
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT