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

Final Container Label (Haloperidol Decanoate Injection, 50 mg (base)/mL)
(click image for full-size original)

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

Final Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) -- Pack of 3
(click image for full-size original)

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

Final Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) -- Pack of 5
(click image for full-size original)

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

Final Container Label (Haloperidol Decanoate Injection, 100 mg (base)/mL)
(click image for full-size original)

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

Final Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) -- Pack of 5
(click image for full-size original)

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

vial label 1ml
(click image for full-size original)

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

carton 50 mg 1s
(click image for full-size original)

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

carton label 10s
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Container Label (Haloperidol Decanoate Injection, 50 mg/mL) – 5 mL Multiple-Dose Vial

vial label 5ml
(click image for full-size original)

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

carton-50-mg-5-ml-1s
(click image for full-size original)

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

carton label 5s
(click image for full-size original)

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

vial label 1 ml
(click image for full-size original)

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

carton 100 mg 1 mL 1s
(click image for full-size original)

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

carton label 5s
(click image for full-size original)

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

carton-100-1-ml-10s
(click image for full-size original)

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

vial label 5 ml
(click image for full-size original)

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

carton-100-5-ml-1s
(click image for full-size original)

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

carton label 5s
(click image for full-size original)
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

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