NDC Code(s) : 67457-580-00, 67457-580-02
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-580
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:67457-580-0225 in 1 CARTON
1NDC:67457-580-002 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202881 06/09/2015

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 200 mcg*/2 mL

NDC 67457-580-02

Dexmedetomidine
Hydrochloride
Injection
200 mcg*/2 mL
(100 mcg/mL) Dexmedetomidine

For Intravenous Infusion Only

MUST BE DILUTED

Rx only     25 x 2 mL Single-Dose Vials

Sterile, Nonpyrogenic

Preservative free

*Each mL contains: 118 mcg of dexmedetomidine hydrochloride
equivalent to 100 mcg of dexmedetomidine; sodium chloride, 9 mg;
water for injection, q.s. The solution is preservative free and contains
no additives or chemical stabilizers. pH is 4.5 to 7.0.

Usual Dosage: See accompanying prescribing information.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room
Temperature.]

Discard unused portion.

MI:580:25C:R1

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

PREMIERPro™Rx is a trademark of
Premier, Inc., used under license.

Dexmedetomidine Hydrochloride Injection 200 mcg/2 mL Carton Label