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Dexmedetomidine Hydrochloride

These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999

Approved
Approval ID

f307de7e-a9ab-4734-abb7-66b4e112bc51

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 20, 2023

Manufacturers
FDA

Gland Pharma Limited

DUNS: 918601238

Products 2

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 Code68083-238
Application NumberANDA209307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexmedetomidine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2023
FDA Product Classification

INGREDIENTS (3)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 4 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dexmedetomidine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-239
Application NumberANDA209307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexmedetomidine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2023
FDA Product Classification

INGREDIENTS (3)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 4 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Dexmedetomidine Hydrochloride - FDA Drug Approval Details