Ketamine Hydrochloride (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial Label (200 mg/20 mL):

NDC 68083-504-01 Rx only
Ketamine Hydrochloride

Injection, USP CIII
200 mg/20 mL
(10 mg/mL)

For Slow Intravenous or Intramuscular Use

20 mL Multiple-Dose Vial

Carton Label (200 mg/20 mL):

NDC 68083-504-10 Rx only Ketamine Hydrochloride

Injection, USP CIII
200 mg/20 mL
(10 mg/mL)
For Slow Intravenous
or Intramuscular Use
20 mL x 10 Multiple-Dose Vials

Vial Label (500 mg/10 mL):

NDC 68083-505-01 Rx only Ketamine

Hydrochloride

Injection, USP

CIII
500 mg/10 mL
(50 mg/mL)
For Slow Intravenous or
Intramuscular Use 10 mL Multiple-Dose Vial

Carton Label (500 mg/10 mL):

NDC 68083-505-10 Rx only

Ketamine Hydrochloride Injection, USP CIII
500 mg/10 mL
(50 mg/mL)
For Slow Intravenous or
Intramuscular Use
10 mL x 10 Multiple-Dose Vials

Vial Label (500 mg/5 mL):

NDC 68083-506-01 Rx only Ketamine Hydrochloride

Injection, USP CIII
500 mg/5 mL
(100 mg/mL)
CONCENTRATE
MUST BE DILUTED PRIOR TO

INTRAVENOUS USE
For Slow Intravenous or Intramuscular Use 5 mL Multiple-Dose Vial

Carton Label (500 mg/5 mL) :

NDC 68083-506-10 Rx only
Ketamine Hydrochloride Injection, USP CIII
500 mg/5 mL
(100 mg/mL)
CONCENTRATE
MUST BE DILUTED PRIOR TO INTRAVENOUS USE
For Slow Intravenous or Intramuscular Use
5 mL x 10 Multiple-Dose Vials

KETAMINE HYDROCHLORIDE ketamine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-504 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETAMINE HYDROCHLORIDE (KETAMINE) KETAMINE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZETHONIUM CHLORIDE SODIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-504-10 10 VIAL in 1 CARTON contains a VIAL 1 20 mL in 1 VIAL This package is contained within the CARTON (68083-504-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216809 01/24/2023

KETAMINE HYDROCHLORIDE ketamine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-505 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETAMINE HYDROCHLORIDE (KETAMINE) KETAMINE 50 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZETHONIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-505-10 10 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (68083-505-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216809 01/24/2023

KETAMINE HYDROCHLORIDE ketamine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-506 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETAMINE HYDROCHLORIDE (KETAMINE) KETAMINE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZETHONIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-506-10 10 VIAL in 1 CARTON contains a VIAL 1 5 mL in 1 VIAL This package is contained within the CARTON (68083-506-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216809 01/24/2023

Labeler — Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited		858971074	ANALYSIS (68083-504), ANALYSIS (68083-505), ANALYSIS (68083-506), MANUFACTURE (68083-504), MANUFACTURE (68083-505), MANUFACTURE (68083-506), PACK (68083-504), PACK (68083-505), PACK (68083-506)

Revised: 02/2023 Gland Pharma Limited