MedPath

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

1faf1ac8-ff9b-4ed9-b562-06dab971173a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 28, 2023

Manufacturers
FDA

CIVICA, INC.

DUNS: 081373942

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 Code72572-127
Application NumberANDA212791
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexmedetomidine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 28, 2023
FDA Product Classification

INGREDIENTS (4)

DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 4 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHIONINEInactive
Quantity: 1 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

dexmedetomidine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72572-128
Application NumberANDA212791
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexmedetomidine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 28, 2023
FDA Product Classification

INGREDIENTS (4)

DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 4 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHIONINEInactive
Quantity: 1 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

DEXMEDETOMIDINE HYDROCHLORIDE - FDA Drug Approval Details