Albuterol Sulfate
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
Approved
Approval ID
2ec64742-5802-49f0-bbbe-95580730c0a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2009
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 Code54868-2472
Application NumberANDA074880
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)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT