NDC Code(s) : 65219-184-01, 65219-184-20, 65219-188-01, 65219-188-10
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ketamine hydrochloride ketamine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-184
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83)
(KETAMINE - UNII:690G0D6V8H) 		KETAMINE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65219-184-2010 in 1 TRAY 07/10/2023
1NDC:65219-184-0120 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 ANDA215808 07/10/2023
ketamine hydrochloride ketamine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-188
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83)
(KETAMINE - UNII:690G0D6V8H) 		KETAMINE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65219-188-1010 in 1 TRAY 07/10/2023
1NDC:65219-188-0110 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 ANDA215808 07/10/2023

LABELER - Fresenius Kabi USA, LLC (013547657)

Establishment
Name Address ID/FEI Business Operations
Fresenius Kabi USA, LLC 840771732 ANALYSIS(65219-184, 65219-188), MANUFACTURE(65219-184, 65219-188)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 20 mL Vial Label

NDC 65219-184-01

Ketamine HCl Injection, USP CIII

200 mg/20 mL

(10 mg/mL)

For Slow Intravenous or Intramuscular Use

20 mL Multiple-Dose Vial

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 20 mL Vial Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 20 mL Tray Label

NDC 65219-184-20

Ketamine HCl Injection, USP CIII

200 mg/20 mL

(10 mg/mL)

For Slow Intravenous or Intramuscular Use

20 mL x 10 Multiple-Dose Vials

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 20 mL Tray Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 10 mL Vial Label

NDC 65219-188-01

Ketamine HCl Injection, USP CIII

500 mg/10 mL

(50 mg/mL)

For Slow Intravenous or Intramuscular Use

10 mL Multiple-Dose Vial

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 10 mL Vial Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 10 mL Tray Label

NDC 65219-188-10

Ketamine HCl Injection, USP CIII

500 mg/10 mL

(50 mg/mL)

For Slow Intravenous or Intramuscular Use

10 mL x 10 Multiple-Dose Vials

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Ketamine HCl Injection, USP 10 mL Tray Label