Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL
Approved
Approval ID
ddc82c42-2e6e-42a6-a30a-e41978e2f4da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 3
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 Code70121-1450
Application NumberANDA208689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
SODIUM SULFITEInactive
Quantity: 1 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Dexamethasone Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1451
Application NumberANDA208689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (7)
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
SODIUM SULFITEInactive
Quantity: 1 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
Dexamethasone Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1452
Application NumberANDA208689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (7)
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
SODIUM SULFITEInactive
Quantity: 1 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT