Haloperidol Decanoate (Page 5 of 5)

HOW SUPPLIED

Haloperidol decanoate injection is a clear colorless/pink to yellow amber oily liquid.

Haloperidol decanoate injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate is available as follows:

NDC	Haloperidol Decanoate Injection (50 mg/mL)	Package Factor
68083-137-10	50 mg/mL* Single-Dose Vial	10 vials per carton
68083-137-02	250 mg/5 mL* Multiple-Dose Vial	1 vial per carton

Haloperidol decanoate injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate is available as follows:

NDC	Haloperidol Decanoate Injection (100 mg/mL)	Package Factor
68083-138-10	100 mg/mL* Single-Dose Vial	10 vials per carton
68083-138-02	500 mg/5 mL* Multiple-Dose Vial	1 vial per carton

* As haloperidol

Storage Conditions

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate or freeze.

PROTECT FROM LIGHT.

Keep in carton until empty.

Keep out of reach of children.
Sterile, Nonpyrogenic.
The container closure is not made with natural rubber latex.
Manufactured by:
Gland Pharma Limited
D.P.Pally, Dundigal Post,

Hyderabad — 500 043, INDIA.
Revised: April 2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 50 mg/mL

NDC 68083-137 -01
Haloperidol
Decanoate Injection
50 mg/mL*

For Intramuscular
Use Only
1 mL Single-Dose Vial Sterile Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 100 mg/mL

NDC 68083-138 -01

Haloperidol

Decanoate Injection

100 mg/mL*

For Intramuscular

Use Only

1 mL Single-Dose Vial

Sterile Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 250 mg/5 mL

NDC 68083-137 -02

Haloperidol Decanoate

Injection

250 mg/5 mL*

(50 mg/mL )

For Intramuscular Use Only

5 mL Multiple-Dose Vial

Sterile Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mg/5 mL

NDC 68083-138 -02
Haloperidol Decanoate
Injection
500 mg/5 mL*
(100 mg/mL)
For Intramuscular Use Only
5 mL Multiple-Dose Vial Sterile Rx only

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-137 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL DECANOATE (HALOPERIDOL) HALOPERIDOL 50 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL 12 mg in 1 mL SESAME OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-137-10 10 VIAL in 1 CARTON contains a VIAL (68083-137-01) 1 NDC:68083-137-01 1 mL in 1 VIAL This package is contained within the CARTON (68083-137-10) 2 NDC:68083-137-02 1 VIAL in 1 CARTON contains a VIAL 2 5 mL in 1 VIAL This package is contained within the CARTON (68083-137-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205241 01/16/2017

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-138 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL DECANOATE (HALOPERIDOL) HALOPERIDOL 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL 12 mg in 1 mL SESAME OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-138-10 10 VIAL in 1 CARTON contains a VIAL (68083-138-01) 1 NDC:68083-138-01 1 mL in 1 VIAL This package is contained within the CARTON (68083-138-10) 2 NDC:68083-138-02 1 VIAL in 1 CARTON contains a VIAL 2 5 mL in 1 VIAL This package is contained within the CARTON (68083-138-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205241 01/16/2017

Labeler — Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited		918601238	ANALYSIS (68083-137), ANALYSIS (68083-138), MANUFACTURE (68083-137), MANUFACTURE (68083-138), PACK (68083-137), PACK (68083-138)

Revised: 04/2023 Gland Pharma Limited