Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection, USPFor Intravenous or Intramuscular Use OnlyRx Only
Approved
Approval ID
799028e2-c0e4-494f-89ff-1b786babc34a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone Sodium Phosphate
PRODUCT DETAILS
NDC Product Code70069-021
Application NumberANDA207442
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 20, 2023
Generic NameDexamethasone Sodium Phosphate
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 24.75 mg in 1 mL
Code: B22547B95K
Classification: IACT