Label: ETOMIDATE injection, solution
- NDC Code(s): 65841-818-07, 65841-818-08
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
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
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
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
-
INGREDIENTS AND APPEARANCE
ETOMIDATE
etomidate injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-818 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598) ETOMIDATE 2 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 1 NDC:65841-818-07 10 in 1 TRAY 04/03/2015 1 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65841-818-08 10 in 1 TRAY 04/03/2015 2 20 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202360 04/03/2015 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 MANUFACTURE(65841-818) , ANALYSIS(65841-818)