NDC Code(s) : 16729-239-30, 16729-239-93
Packager : Accord Healthcare Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DexmedetomidineDexmedetomidine INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-239
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I)
(DEXMEDETOMIDINE - UNII:67VB76HONO) 		DEXMEDETOMIDINE100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16729-239-9325 in 1 CARTON 21/12/2016
1NDC:16729-239-302 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204023 12/21/2016

LABELER - Accord Healthcare Inc.(604222237)

REGISTRANT - Accord Healthcare Inc.(604222237)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Ltd 725927649 manufacture(16729-239), analysis(16729-239)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Ltd 915837971 manufacture(16729-239), analysis(16729-239)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Dexmedetomidine HCL Injection

NDC 16729- 239-30

200 mcg (Dexmedetomidine)/2 mL [100 mcg (Dexmedetomidine)/mL] Label

Rx only

For IV use
MUST BE DILUTED

Dexmedetomidine100 mcg-mL-label

Dexmedetomidine HCL Injection

NDC 16729- 239-93

200 mcg (Dexmedetomidine)/2 mL [100 mcg (Dexmedetomidine)/mL] Carton

Rx only

For IV use
MUST BE DILUTED

Dexmedetomidine100 mcg-mL-label

Dexmedetomidine HCL Injection

NDC 16729- 239-30

200 mcg (Dexmedetomidine)/2 mL [100 mcg (Dexmedetomidine)/mL] Label

Rx only

For IV use
MUST BE DILUTED

Dexmedetomidine100 mcg-mL-label

Dexmedetomidine HCL Injection

NDC 16729- 239-93

200 mcg (Dexmedetomidine)/2 mL [100 mcg (Dexmedetomidine)/mL] Carton

Rx only

For IV use
MUST BE DILUTED

Dexmedetomidine100 mcg-mL-label