NDC Code(s) : 42023-137-10, 42023-138-10, 42023-139-10
Packager : Par Pharmaceutical Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ketamine hydrochlorideketamine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-137
Route of Administration INTRAVENOUS, INTRAMUSCULAR 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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-137-1010 in 1 CARTON 01/06/2012
120 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
NDA authorized generic NDA016812 06/01/2012 05/06/2018
ketamine hydrochlorideketamine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-138
Route of Administration INTRAVENOUS, INTRAMUSCULAR 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)
sodium chloride(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-138-1010 in 1 CARTON 01/06/2012
110 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
NDA authorized generic NDA016812 06/01/2012 04/29/2018
ketamine hydrochlorideketamine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-139
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketamine hydrochloride(UNII: O18YUO0I83)
(ketamine - UNII:690G0D6V8H) 		ketamine100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzethonium chloride(UNII: PH41D05744)
sodium chloride(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-139-1010 in 1 CARTON 01/06/2012
15 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
NDA authorized generic NDA016812 06/01/2012 05/12/2018

PRINCIPAL DISPLAY PANEL

NDC 42023-137-10
Rx Only

Ketamine HCl
Injection, USP

CIII

200 mg/20 mL
(10 mg/mL)

For Slow Intravenous (IV) or Intramuscular (IM) Use

20 mL x 10 Multiple Dose Vials

Ketamine Carton 200mg/20mL (10mg/mL)

PRINCIPAL DISPLAY PANEL

NDC 42023-138-10
Rx Only

Ketamine HCl
Injection, USP

CIII

500 mg/10 mL
(50 mg/mL)

For Slow Intravenous (IV) or Intramuscular (IM) Use

10 mL x 10 Multiple Dose Vials

Ketamine Carton 500mg/10mL (50 mg/mL)

PRINCIPAL DISPLAY PANEL

NDC 42023-139-10
Rx Only

Ketamine HCl
Injection, USP

CIII

CONCENTRATE
500 mg/5 mL
(100 mg/mL)

For Slow Intravenous (IV) or Intramuscular (IM) Use

5 mL x 10 Multiple Dose Vials
MUST BE DILUTED PRIOR TO IV USE

Ketamine Carton 500mg/5mL (100mg/mL)