Baycadron
BAYCADRON™ ELIXIR (Dexamethasone Elixir, USP 0.5 mg/5 mL)
Approved
Approval ID
e59d3b87-af2e-4262-b89d-e95aa79f11b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2009
Manufacturers
FDA
Wockhardt USA, LLC
DUNS: 170508365
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-810
Application NumberANDA088254
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2009
FDA Product Classification
INGREDIENTS (10)
DexamethasoneActive
Quantity: 0.5 mg in 5 mL
Code: 7S5I7G3JQL
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT
raw sugarInactive
Code: 8M707QY5GH
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT