Dexamethasone
DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL
Approved
Approval ID
7b51ffce-ec64-4b49-8870-b9666537c541
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
Marlex Pharmaceuticals, Inc
DUNS: 782540215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
PRODUCT DETAILS
NDC Product Code10135-795
Application NumberANDA084754
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 22, 2025
Generic NameDexamethasone
INGREDIENTS (11)
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
DEXAMETHASONEActive
Quantity: 0.5 mg in 5 mL
Code: 7S5I7G3JQL
Classification: ACTIB