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Precedex

These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection, for intravenous use Initial U.S. Approval: 1999

Approved
Approval ID

4419162d-81d4-49bd-96de-1729440bdb74

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 22, 2023

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 4

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 Code0409-1174
Application NumberNDA021038
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 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 Code0409-1454
Application NumberNDA021038
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
FDA Product Classification

INGREDIENTS (3)

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

DEXMEDETOMIDINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-3301
Application NumberNDA021038
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
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 Code0409-2815
Application NumberNDA021038
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
FDA Product Classification

INGREDIENTS (3)

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

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