Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection, USP
Approved
Approval ID
836f8017-d023-410b-8515-ec776e73ca59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2019
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 4
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 Code67457-418
Application NumberANDA040803
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (8)
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
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Quantity: 10 mg in 1 mL
Code: RS7A450LGA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Dexamethasone Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-419
Application NumberANDA040803
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (8)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Quantity: 10 mg in 1 mL
Code: RS7A450LGA
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dexamethasone Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-483
Application NumberANDA040802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (8)
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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 Code67457-484
Application NumberANDA040803
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (8)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Quantity: 10 mg in 1 mL
Code: RS7A450LGA
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.11 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT