Dexmedetomidine Hydrochloride
These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE injection for intravenous useInitial U.S. Approval: 1999
Approved
Approval ID
4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2018
Manufacturers
FDA
Sun Pharmaceuticals Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXMEDETOMIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-596
Application NumberANDA202126
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 20, 2018
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 100 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT