DEXMEDETOMIDINE
These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval: 1999
Approved
Approval ID
aa450b4b-4969-465d-b7f2-8da380bbdbed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2020
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXMEDETOMIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-432
Application NumberANDA204023
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXMEDETOMIDINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 18, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 100 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM