Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection, USP Rx only
Approved
Approval ID
69344707-904d-7ba2-e053-2a91aa0a31f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2023
Manufacturers
FDA
Medical Purchasing Solutions, LLC
DUNS: 601458529
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 Code71872-7091
Application NumberANDA087702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 23, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CITRATEInactive
Quantity: 16.5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM SULFITEInactive
Quantity: 1.5 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.42 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
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