NDC Code(s) : 0069-0006-02, 0069-0006-01, 0069-0006-04, 0069-0006-03
Packager : Pfizer Laboratories Div Pfizer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EtomidateEtomidate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0006
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0006-0110 in 1 CARTON
1NDC:0069-0006-0210 mL in 1 VIAL
2NDC:0069-0006-0310 in 1 CARTON
2NDC:0069-0006-0420 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

20 mg

NDC 0069-0006-02

10 mL Single Dose Vial

etomidate injection

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

Discard Unused Portion

Rx only

Etomidate injection 20 mg per 10 ml vial label

NDC 0069-0006-01

Contains 10 of NDC 0069-0006-02

Rx only

10 x 10 mL Single Dose Vials

etomidate injection

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

Pfizer Injectables

Etomidate injection 20 mg per 10 ml vial label

40 mg

NDC 0069-0006-04

20 mL Single Dose Vial

etomidate injection

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

Discard Unused Portion

Rx only

Pfizer Injectables

Etomidate injection 20 mg per 10 ml vial label

NDC 0069-0006-03

Contains 10 of NDC 0069-0006-04

Rx only

10 x 20 mL Single Dose Vials

etomidate injection

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

Pfizer Injectables

Etomidate injection 20 mg per 10 ml vial label