DEXMEDETOMIDINE HYDROCHLORIDE - dexmedetomidine hydrochloride injection, solution, concentrate
Zydus Lifesciences Limited

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DEXMEDETOMIDINE HYDROCHLORIDE INJECTION

PRINCIPAL DISPLAY PANEL

200 MCG/2 ML CONTAINER LABEL

NDC 70771-1319-1

Dexmedetomidine

Hydrochloride Injection

200 mcg/2 mL

(100 mcg/mL)

For Intravenous Infusion Use

MUST BE DILUTED

2 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 200 MCG/2 ML CARTON LABEL

NDC 70771-1319-7

Dexmedetomidine

Hydrochloride Injection

200 mcg/2 mL

(100 mcg/mL)

For Intravenous Infusion Use

MUST BE DILUTED

25 X 2 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride injection, solution, concentrate

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)	DEXMEDETOMIDINE	100 ug in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1319-7	25 in 1 CARTON	06/14/2018
1	NDC:70771-1319-1	2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206798	06/14/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1319) , MANUFACTURE(70771-1319)

Revised: 10/2022

Document Id: ef257e34-8862-4020-895d-6d12f419f669

Set id: 263b1586-c68d-4003-8284-1512e4da1013

Version: 3

Effective Time: 20221017

Zydus Lifesciences Limited