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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-021
Application NumberANDA207442
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 20, 2023
FDA Product Classification
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