DEXAMETHASONE Sodium Phosphate
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
Approved
Approval ID
5564ee46-7bd7-4b2a-ad51-d01f7fda0461
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6099
Application NumberANDA081126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 5, 2010
FDA Product Classification
INGREDIENTS (6)
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIB
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT