DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride injection, solution, concentrate 
Cadila Healthcare 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

Dexmedetomidine Hydrochloride Injection - Container Label

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 Injection - Carton Label
DEXMEDETOMIDINE HYDROCHLORIDE 
dexmedetomidine hydrochloride injection, solution, concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1319
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO) DEXMEDETOMIDINE100 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1319-725 in 1 CARTON06/14/2018
1NDC:70771-1319-12 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20679806/14/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1319) , MANUFACTURE(70771-1319)

Revised: 10/2020
Document Id: ce023b03-c227-49e5-8808-cd4c6ba8da38
Set id: 263b1586-c68d-4003-8284-1512e4da1013
Version: 2
Effective Time: 20201012
 
Cadila Healthcare Limited