HALOPERIDOL DECANOATE (Page 5 of 5)

HOW SUPPLIED

Haloperidol Decanoate Injection is clear, slightly viscous, colorless to pink or amber solution supplied as follows:

Haloperidol Decanoate Injection 50 mg for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate.

Haloperidol Decanoate Injection 100 mg for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate.

NDC No.	Strength	Size
70069- 030 -03	50 mg/mL	1 mL fill in 1 mL Ampule, in packages of 3
70069- 030 -05		1 mL fill in 1 mL Ampule, in packages of 5
70069- 031 -05	100 mg/mL	1 mL fill in 1 mL Ampule, in packages of 5
70069- 381 -01	50 mg/mL	1 mL fill in 2 mL Single-Dose Vial, in packages of 1
70069- 381 -10		1 mL fill in 2 mL Single-Dose Vial, in packages of 10
70069- 382 -05	250 mg/5mL (50 mg/mL)	5 mL fill in 5 mL Multiple-Dose Vial, in packages of 5
70069- 382 -01		5 mL fill in 5 mL Multiple-Dose Vial, in package of 1
70069- 383 -01	100 mg/mL	1 mL fill in 2 mL Single-Dose Vial, in packages of 1
70069- 383 -05		1 mL fill in 2 mL Single-Dose Vial, in packages of 5
70069- 383 -10		1 mL fill in 2 mL Single-Dose Vial, in packages of 10
70069- 384 -05	500 mg/5mL (100 mg/mL)	5 mL fill in 5 mL Multiple-Dose Vial, in packages of 5
70069- 384 -01		5 mL fill in 5 mL Multiple-Dose Vial, in package of 1

Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from Light.

Keep out of reach of children.

For Product Inquiry call 1-800-417-9175.

Manufactured for:

Somerset Therapeutics, LLC

Hollywood, FL 33024

Made in India

Code No.: KR/DRUGS/KTK/28/289/97

PSSO0398

ST-HAD/P/05

Revised: August 2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label (Haloperidol Decanoate Injection, 50 mg/mL) – 1 mL Ampule

Carton Label (Haloperidol Decanoate Injection, 50 mg/mL) – Pack of 3’s

Carton Label (Haloperidol Decanoate Injection, 50 mg/mL) – Pack of 5’s

Container Label (Haloperidol Decanoate Injection, 100 mg/mL) – 1 mL Ampule

Carton Label (Haloperidol Decanoate Injection, 100 mg/mL) – Pack of 5’s

Container Label (Haloperidol Decanoate Injection, 50 mg/mL) – 1 mL Single-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 50 mg/mL) – 1 x 1 mL Single-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 50 mg/mL) – 10 x 1 mL Single-Dose Vials

Container Label (Haloperidol Decanoate Injection, 50 mg/mL) – 5 mL Multiple-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 50 mg/mL) – 1 x 5 mL Multiple-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 50 mg/mL) – 5 x 5 mL Multiple-Dose Vials

Container Label (Haloperidol Decanoate Injection, 100 mg/mL) – 1 mL Single-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 100 mg/mL) – 1 x 1 mL Single-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 100 mg/mL) – 5 x 1 mL Single-Dose Vials

Carton Label (Haloperidol Decanoate Injection, 100 mg/mL) – 10 x 1 mL Single-Dose Vials

Container Label (Haloperidol Decanoate Injection, 100 mg/mL) – 5 mL Multiple-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 100 mg/mL) – 1 x 5 mL Multiple-Dose Vial

Carton Label (Haloperidol Decanoate Injection, 100 mg/mL) – 5 x 5 mL Multiple-Dose Vials

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-030 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 SESAME OIL

Product Characteristics Color YELLOW (clear, slightly viscous, colorless to pink) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-030-05 5 AMPULE in 1 CARTON contains a AMPULE (70069-030-01) 1 NDC:70069-030-01 1 mL in 1 AMPULE This package is contained within the CARTON (70069-030-05) 2 NDC:70069-030-03 3 AMPULE in 1 CARTON contains a AMPULE (70069-030-01) 2 NDC:70069-030-01 1 mL in 1 AMPULE This package is contained within the CARTON (70069-030-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209101 07/03/2018

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-031 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 SESAME OIL

Product Characteristics Color YELLOW (clear, slightly viscous, colorless to pink) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-031-05 5 AMPULE in 1 CARTON contains a AMPULE (70069-031-01) 1 NDC:70069-031-01 1 mL in 1 AMPULE This package is contained within the CARTON (70069-031-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209101 07/03/2018

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-381 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 SESAME OIL

Product Characteristics Color YELLOW (clear, slightly viscous, colorless to pink) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-381-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70069-381-01) 2 NDC:70069-381-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 2 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70069-381-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209101 04/04/2019

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-382 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 SESAME OIL

Product Characteristics Color YELLOW (clear, slightly viscous, colorless to pink) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-382-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70069-382-01) 2 NDC:70069-382-05 5 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 2 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70069-382-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209101 04/04/2019

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-383 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 SESAME OIL

Product Characteristics Color YELLOW (clear, slightly viscous, colorless to pink) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-383-05 5 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70069-383-05) 2 NDC:70069-383-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 2 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70069-383-10) 3 NDC:70069-383-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 3 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70069-383-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209101 04/04/2019

HALOPERIDOL DECANOATE haloperidol decanoate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-384 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 SESAME OIL

Product Characteristics Color YELLOW (clear, slightly viscous, colorless to pink) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-384-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70069-384-01) 2 NDC:70069-384-05 5 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 2 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70069-384-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209101 04/04/2019

Labeler — Somerset Therapeutics, LLC (079947873)

Registrant — Somerset Therapeutics, LLC (079947873)

Establishment
Name	Address	ID/FEI	Operations
Wintac Limited		677236695	ANALYSIS (70069-030), ANALYSIS (70069-031), ANALYSIS (70069-381), ANALYSIS (70069-382), ANALYSIS (70069-383), ANALYSIS (70069-384), LABEL (70069-030), LABEL (70069-031), LABEL (70069-381), LABEL (70069-382), LABEL (70069-383), LABEL (70069-384), PACK (70069-030), PACK (70069-031), PACK (70069-381), PACK (70069-382), PACK (70069-383), PACK (70069-384), MANUFACTURE (70069-030), MANUFACTURE (70069-031), MANUFACTURE (70069-381), MANUFACTURE (70069-382), MANUFACTURE (70069-383), MANUFACTURE (70069-384)

Revised: 08/2021 Somerset Therapeutics, LLC