NDC Code(s) : 0517-0780-01, 0517-0780-10, 0517-0781-01, 0517-0781-10
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EtomidateEtomidate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0780
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETOMIDATE(UNII: Z22628B598)
(ETOMIDATE - UNII:Z22628B598) 		ETOMIDATE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0780-1010 in 1 CARTON 30/06/2010
1NDC:0517-0780-0110 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 ANDA078867 06/30/2010
EtomidateEtomidate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0781
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETOMIDATE(UNII: Z22628B598)
(ETOMIDATE - UNII:Z22628B598) 		ETOMIDATE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0781-1010 in 1 CARTON 30/06/2010
1NDC:0517-0781-0120 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 ANDA078867 06/30/2010

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mL Label

NDC 0517-0780-01

ETOMIDATE
INJECTION

20 mg/10 mL
(2 mg/mL)

10 mL SINGLE DOSE VIAL

FOR INTRAVENOUS USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

10 mL Container Label

PRINCIPAL DISPLAY PANEL - 20 mL Label

NDC 0517-0781-01

ETOMIDATE
INJECTION

40 mg/20 mL
(2 mg/mL)

20 mL SINGLE DOSE VIAL

FOR INTRAVENOUS USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

10 mL Container Label

PRINCIPAL DISPLAY PANEL - 10 mL Carton

NDC 0517-0780-10

ETOMIDATE
INJECTION

20 mg/10 mL
(2 mg/mL)

10 x 10 mL

SINGLE DOSE VIALS

FOR INTRAVENOUS USE

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY  11967

10 mL Container Label

PRINCIPAL DISPLAY PANEL - 20 mL Carton

NDC 0517-0781-10

ETOMIDATE
INJECTION

40 mg/20 mL
(2 mg/mL)

10 x 20 mL
SINGLE DOSE VIALS

FOR INTRAVENOUS USE

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY  11967

10 mL Container Label