Albuterol Sulfate
Albuterol Sulfate Syrup
Approved
Approval ID
8d215fe3-1cf6-4bb3-b005-75f1a9d62235
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2012
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 Code54868-2887
Application NumberANDA074749
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2012
FDA Product Classification
INGREDIENTS (9)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2 mg in 5 mL
Code: 021SEF3731
Classification: ACTIM
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT