Ketamine Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 50 mg/mL

NDC 67457-001-10

Ketamine Hydrochloride
Injection, USP CIII

500 mg/10 mL*
(50 mg/mL)

For Intramuscular or Slow Intravenous Use

Rx only 10 x 10 mL Multi-Dose Vials

Sterile

*Each mL contains:

Ketamine hydrochloride equivalent to 50 mg of ketamine with a pH range of 3.5 to 5.5. Also
contains not more than 0.1 mg/mL of benzethonium chloride added as a preservative.

Color of solution may vary from colorless to very slightly yellowish and may darken upon
prolonged exposure to light. This darkening does not affect potency.

Do not use if precipitate appears.

Warning: Keep this and all drugs out of the reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light. Retain in carton until time of use.

Usual Dosage: See accompanying prescribing information.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional Galway, Ireland

MI:001:10C:R5

Mylan.com

PRINCIPAL DISPLAY PANEL — 100 mg/mL

NDC 67457-108-10

Ketamine Hydrochloride
Injection, USP CIII

1,000 mg/10 mL*
(100 mg/mL)

For Intramuscular or Slow Intravenous Use

Must Be Diluted Before Intravenous Use

Rx only 10 x 10 mL Multi-Dose Vials

Sterile

*Each mL contains:

Ketamine hydrochloride equivalent to
100 mg of ketamine with a pH range of 3.5 to 5.5. Also contains not more than 0.1 mg/mL
of benzethonium chloride added as a preservative.

Color of solution may vary from colorless to very slightly yellowish and may darken upon prolonged exposure to light.
This darkening does not affect potency.

Do not use if precipitate appears.

Warning: Keep this and all drugs out of the reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light. Retain in carton until time of use.

Usual Dosage: See accompanying prescribing information.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional Galway, Ireland

MI:108:10C:R5

Mylan.com

KETAMINE HYDROCHLORIDE ketamine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-181 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 0.1 mg in 1 mL SODIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-181-20 10 VIAL in 1 CARTON contains a VIAL (67457-181-00) 1 NDC:67457-181-00 20 mL in 1 VIAL This package is contained within the CARTON (67457-181-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076092 06/04/2013 10/31/2023

KETAMINE HYDROCHLORIDE ketamine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-001 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 0.1 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-001-10 10 VIAL in 1 CARTON contains a VIAL (67457-001-00) 1 NDC:67457-001-00 10 mL in 1 VIAL This package is contained within the CARTON (67457-001-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076092 06/04/2013 08/31/2022

KETAMINE HYDROCHLORIDE ketamine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-108 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 0.1 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-108-10 10 VIAL in 1 CARTON contains a VIAL (67457-108-00) 1 NDC:67457-108-00 10 mL in 1 VIAL This package is contained within the CARTON (67457-108-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076092 06/04/2013 08/31/2023

Labeler — Mylan Institutional LLC (790384502)

Revised: 03/2019 Mylan Institutional LLC