Etomidate

ETOMIDATE- etomidate injection, solution
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial Label 10 mL

Zydus Pharmaceuticals

NDC 65841-818-07

Etomidate Injection, USP

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

10 mL, Single-Dose Vial

Rx Only

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(click image for full-size original)

Carton Label 10 mL

Zydus Pharmaceuticals

NDC 65841-818-07

Etomidate injection, USP

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

10 x 10 mL, Single-Dose Vials

Rx Only

figure03
(click image for full-size original)

Vial Label 20 mL

Zydus Pharmaceuticals

NDC 65841-818-08

Etomidate injection, USP

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

20 mL, Single-Dose Vial

Rx Only

figure04
(click image for full-size original)

Carton Label 20 mL

Zydus Pharmaceuticals

NDC 65841-818-08

Etomidate injection, USP

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

10 x 20 mL, Single-Dose Vials

Rx Only

figure05
(click image for full-size original)
ETOMIDATE
etomidate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-818
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETOMIDATE (ETOMIDATE) ETOMIDATE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL 0.35 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-818-07 10 VIAL in 1 TRAY contains a VIAL
1 10 mL in 1 VIAL This package is contained within the TRAY (65841-818-07)
2 NDC:65841-818-08 10 VIAL in 1 TRAY contains a VIAL
2 20 mL in 1 VIAL This package is contained within the TRAY (65841-818-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202360 04/03/2015
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 MANUFACTURE (65841-818), ANALYSIS (65841-818)

Revised: 07/2020 Cadila Healthcare Limited

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