HALOPERIDOL DECANOATE- haloperidol decanoate injection 
Zydus Lifesciences Limited

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Haloperidol Decanoate Injection
For Intramuscular Injection Only
Rx 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0004
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72785-0004-610 in 1 CARTON11/14/201908/31/2023
11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:72785-0004-93 in 1 CARTON11/14/201908/31/2023
21 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21118011/14/201908/31/2023
HALOPERIDOL DECANOATE 
haloperidol decanoate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0005
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72785-0005-11 in 1 CARTON11/14/201908/31/2023
15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:72785-0005-55 in 1 CARTON11/14/201908/31/2023
25 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21118011/14/201908/31/2023
HALOPERIDOL DECANOATE 
haloperidol decanoate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0006
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72785-0006-11 in 1 CARTON11/14/201908/31/2023
11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:72785-0006-55 in 1 CARTON11/14/201908/31/2023
21 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21118011/14/201908/31/2023
HALOPERIDOL DECANOATE 
haloperidol decanoate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0007
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72785-0007-11 in 1 CARTON11/14/201908/31/2023
15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:72785-0007-55 in 1 CARTON11/14/201908/31/2023
25 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21118011/14/201908/31/2023
Labeler - Zydus Lifesciences Limited (873671928)
Registrant - Zydus Lifesciences Limited (873671928)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928ANALYSIS(72785-0004, 72785-0005, 72785-0006, 72785-0007) , MANUFACTURE(72785-0004, 72785-0005, 72785-0006, 72785-0007)

Revised: 9/2023
 
Zydus Lifesciences Limited