Haloperidol Decanoate InjectionFor Intramuscular Injection OnlyRx only

PRINCIPAL DISPLAY PANEL - 50 mg/mL Vial Label

NDC 72785-0004-1

Haloperidol

Decanoate

Injection

50 mg/mL*

For Intramuscular Use Only

1 mL Single-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 50 mg per mL Vial Label

PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (50 mg/mL) Vial Label

NDC 72785-0005-1

Haloperidol

Decanoate Injection

250 mg/5 mL*

(50 mg/mL)

For Intramuscular Use Only

5 mL Multiple-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 250 mg per 5 mL (50 mg per mL) Vial Label

PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Label

NDC 72785-0006-1

Haloperidol

Decanoate

Injection

100 mg/mL*

For Intramuscular Use Only

1 mL Single-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 100 mg per mL Vial Label

PRINCIPAL DISPLAY PANEL - 500 mg/5 mL (100 mg/mL) Vial Label

NDC 72785-0007-1

Haloperidol

Decanoate Injection

500 mg/5 mL*

(100 mg/mL)

For Intramuscular Use Only

5 mL Multiple-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 500 mg per 5 mL (100 mg per mL) Vial Label

PRINCIPAL DISPLAY PANEL –

50 mg/mL Carton (3 vials per carton)

NDC 72785-0004-9

Haloperidol Decanoate

Injection

50 mg/mL*

For Intramuscular Use Only

3 X 1 mL

Single-Dose Vials

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 50 mg per mL Carton (3 Vials per carton)

PRINCIPAL DISPLAY PANEL –

50 mg/mL Carton (10 vials per carton)

NDC 72785-0004-6

Haloperidol Decanoate

Injection

50 mg/mL*

For Intramuscular Use Only

10 X 1 mL Single-Dose Vials

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 50 mg per mL Carton (10 Vials per carton)

PRINCIPAL DISPLAY PANEL –

250 mg/5 mL (50 mg/mL) Carton (1 vial per carton)

NDC 72785-0005-1

Haloperidol

Decanoate

Injection

250 mg/5 mL*

(50 mg/mL)

For Intramuscular Use Only

5 mL

Multiple-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 250 mg per 5 mL Carton (1 Vial per carton)

PRINCIPAL DISPLAY PANEL –

250 mg/5 mL (50 mg/mL) Carton (5 vials per carton)

NDC 72785-0005-5

Haloperidol Decanoate Injection

250 mg/5 mL*

(50 mg/mL)

For Intramuscular Use Only

5 X 5 mL Multiple-Dose Vials

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 250 mg per 5 mL Carton (5 Vials per carton)

PRINCIPAL DISPLAY PANEL –

100 mg/mL Carton (1 vial per carton)

NDC 72785-0006-1

Haloperidol

Decanoate

Injection

100 mg/mL*

For Intramuscular Use Only

1 mL

Single-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 100 mg per mL Carton (1 Vial per carton)

PRINCIPAL DISPLAY PANEL –

100 mg/mL Carton (5 vials per carton)

NDC 72785-0006-5

Haloperidol Decanoate Injection

100 mg/mL*

For Intramuscular Use Only

5 X 1 mL Single-Dose Vials

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 100 mg per mL Carton (5 Vials per carton)

PRINCIPAL DISPLAY PANEL –

500 mg/5 mL (100 mg/mL) Carton (1 vial per carton)

NDC 72785-0007-1

Haloperidol

Decanoate

Injection

500 mg/5 mL*

(100 mg/mL)

For Intramuscular Use Only

5 mL Multiple-Dose Vial

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 500 mg per 5 mL Carton (1 Vial per carton)

PRINCIPAL DISPLAY PANEL –

500 mg/5 mL (100 mg/mL) Carton (5 vials per carton)

NDC 72785-0007-5

Haloperidol Decanoate Injection

500 mg/5 mL*

(100 mg/mL)

For Intramuscular Use Only

5 X 5 mL Multiple-Dose Vials

Sterile

Rx only

zydus pharmaceuticals

Haloperidol decanoate Injection, 500 mg per 5 mL Carton (5 Vials per carton)

HALOPERIDOL DECANOATE
haloperidol decanoate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72785-0004
Route of Administration	INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SESAME OIL (UNII: QX10HYY4QV)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0004-6	10 in 1 CARTON	11/14/2019
1	NDC:72785-0004-1	1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC:72785-0004-9	3 in 1 CARTON	11/14/2019
2	NDC:72785-0004-1	1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211180	11/14/2019

HALOPERIDOL DECANOATE
haloperidol decanoate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72785-0005
Route of Administration	INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SESAME OIL (UNII: QX10HYY4QV)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0005-1	1 in 1 CARTON	11/14/2019
1		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2	NDC:72785-0005-5	5 in 1 CARTON	11/14/2019
2		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211180	11/14/2019

HALOPERIDOL DECANOATE
haloperidol decanoate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72785-0006
Route of Administration	INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SESAME OIL (UNII: QX10HYY4QV)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0006-1	1 in 1 CARTON	11/14/2019
1		1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC:72785-0006-5	5 in 1 CARTON	11/14/2019
2		1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211180	11/14/2019

HALOPERIDOL DECANOATE
haloperidol decanoate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72785-0007
Route of Administration	INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SESAME OIL (UNII: QX10HYY4QV)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0007-1	1 in 1 CARTON	11/14/2019
1		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2	NDC:72785-0007-5	5 in 1 CARTON	11/14/2019
2		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211180	11/14/2019

Labeler - Zydus Lifesciences Limited (873671928)

Registrant - Zydus Lifesciences Limited (873671928)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		873671928	ANALYSIS(72785-0004, 72785-0005, 72785-0006, 72785-0007) , MANUFACTURE(72785-0004, 72785-0005, 72785-0006, 72785-0007)