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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

c958aeb4-69ce-c3e2-e053-2a95a90a6d8d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2023

Manufacturers
FDA

Piramal Critical Care Inc

DUNS: 805600439

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 Code66794-234
Application NumberANDA209307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexmedetomidine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (3)

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

Dexmedetomidine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66794-235
Application NumberANDA209307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexmedetomidine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (3)

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

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Dexmedetomidine Hydrochloride - FDA Drug Approval Details