Etomidate Injection, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial Label 10 mL

Zydus Pharmaceuticals

NDC 65841-818-07

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

10 mL, Single-Dose Vial

Rx Only

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

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

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

ETOMIDATE
etomidate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-818
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598)	ETOMIDATE	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.35 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-818-07	10 in 1 TRAY	04/03/2015	03/25/2025
1		10 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC:65841-818-08	10 in 1 TRAY	04/03/2015	03/25/2025
2		20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202360	04/03/2015	06/03/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	MANUFACTURE(65841-818) , ANALYSIS(65841-818)

Revised: 6/2025

Document Id: c7644c44-444b-4323-9f29-0e82221fed63

Set id: 428d51f4-fb7a-4efe-a87e-698d46ef8a24

Version: 6

Effective Time: 20250603

Zydus Lifesciences Limited