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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

f21d674a-7f5c-4143-82ae-83c43c503084

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 28, 2023

Manufacturers
FDA

Slayback Pharma LLC

DUNS: 967770848

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 Code71225-132
Application NumberANDA212791
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexmedetomidine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2022
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
DEXMEDETOMIDINE HYDROCHLORIDEActive
Quantity: 4 ug in 1 mL
Code: 1018WH7F9I
Classification: ACTIM
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 Code71225-133
Application NumberANDA212791
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexmedetomidine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2022
FDA Product Classification

INGREDIENTS (4)

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

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DEXMEDETOMIDINE HYDROCHLORIDE - FDA Drug Approval Details