NDC Code(s) : 67457-456-00, 67457-456-21, 67457-477-00, 67457-477-10
Packager : Mylan Institutional LLC

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:67457-456
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)0.35 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-456-2110 in 1 CARTON
1NDC:67457-456-0010 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078289 02/03/2012

INGREDIENTS AND APPEARANCE

EtomidateEtomidate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-477
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)0.35 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-477-1010 in 1 CARTON
1NDC:67457-477-0020 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078289 02/03/2012

PRINCIPAL DISPLAY PANEL

Etomidate Injection, USP

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

Discard Unused Portion

10 X 10 mL Single Dose Vials

Rx only

etomidate injection USP - vial label

Etomidate Injection, USP

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

Discard Unused Portion

10 X 20 mL Single Dose Vials

Rx only

etomidate injection USP - vial label