Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection, USP
Approved
Approval ID
d21f3055-8a8a-4797-93e2-c8f582cbdae1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
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 Code50090-1922
Application NumberANDA040803
Marketing CategoryC73584
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateDecember 3, 2018
Generic NameDexamethasone Sodium Phosphate
INGREDIENTS (8)
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.11 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Quantity: 10 mg in 1 mL
Code: RS7A450LGA
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
Dexamethasone Sodium Phosphate
PRODUCT DETAILS
NDC Product Code50090-2313
Application NumberANDA040803
Marketing CategoryC73584
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateDecember 3, 2018
Generic NameDexamethasone Sodium Phosphate
INGREDIENTS (8)
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Quantity: 10 mg in 1 mL
Code: RS7A450LGA
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
EDETATE DISODIUMInactive
Quantity: 0.11 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT