Dexamethasone
DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL
Approved
Approval ID
320747b3-5cf1-4e0c-b670-c6a9e72a8845
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
STI Pharma LLC
DUNS: 832714070
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 Code54879-003
Application NumberANDA084754
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (11)
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DEXAMETHASONEActive
Quantity: 0.5 mg in 5 mL
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT