Haloperidol Decanoate

HALOPERIDOL DECANOATE- haloperidol decanoate injection
Cadila Healthcare Limited

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)
HALOPERIDOL DECANOATE
haloperidol decanoate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0004
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
SESAME OIL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72785-0004-6 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (72785-0004-1)
1 NDC:72785-0004-1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72785-0004-6)
2 NDC:72785-0004-9 3 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (72785-0004-1)
2 NDC:72785-0004-1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72785-0004-9)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 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
SESAME OIL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72785-0005-1 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 (72785-0005-1)
2 NDC:72785-0005-5 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 (72785-0005-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 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
SESAME OIL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72785-0006-1 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 (72785-0006-1)
2 NDC:72785-0006-5 5 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 (72785-0006-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 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
SESAME OIL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72785-0007-1 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 (72785-0007-1)
2 NDC:72785-0007-5 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 (72785-0007-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211180 11/14/2019
Labeler — Cadila Healthcare Limited (873671928)
Registrant — Cadila Healthcare Limited (873671928)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 873671928 ANALYSIS (72785-0004), ANALYSIS (72785-0005), ANALYSIS (72785-0006), ANALYSIS (72785-0007), MANUFACTURE (72785-0004), MANUFACTURE (72785-0005), MANUFACTURE (72785-0006), MANUFACTURE (72785-0007)

Revised: 07/2020 Cadila Healthcare Limited

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