ETOMIDATE- etomidate injection, solution 
Cadila Healthcare Limited

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Etomidate Injection, USP

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

figure02

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

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

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
ETOMIDATE 
etomidate injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-818
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598) ETOMIDATE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.35 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-818-0710 in 1 TRAY04/03/2015
110 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:65841-818-0810 in 1 TRAY04/03/2015
220 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20236004/03/2015
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198MANUFACTURE(65841-818) , ANALYSIS(65841-818)

Revised: 7/2020
Document Id: a8424e0e-aa39-4127-8dd9-9e07d24d2f81
Set id: 428d51f4-fb7a-4efe-a87e-698d46ef8a24
Version: 4
Effective Time: 20200728
 
Cadila Healthcare Limited