Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Injection, USP Preservative-Free Rx only
Approved
Approval ID
0ce0211c-86fa-4056-b161-0950639df6d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
Armas Pharmaceuticals
DUNS: 098405973
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 Code72485-118
Application NumberANDA217797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (5)
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT