Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection, USP
Approved
Approval ID
ce25183b-cd67-4997-8de9-df59b750883b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code76045-210
Application NumberANDA203129
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, SOFT TISSUE
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (5)
Dexamethasone Sodium PhosphateActive
Quantity: 4 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIM
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Trisodium citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT