Albuterol Sulfate
Albuterol Sulfate Inhalation Solution 0.63 mg* / 3 mL and 1.25 mg* / 3 mL
Approved
Approval ID
774b1ef9-015e-4e8e-9c52-d305de1ef85e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5709
Application NumberANDA076355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 12, 2010
FDA Product Classification
INGREDIENTS (4)
ALBUTEROL SULFATEActive
Quantity: 1.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT