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NDC 72785-0007-01 Haloperidol decanoate 100 mg/mL Details

Haloperidol decanoate 100 mg/mL

Haloperidol decanoate is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is HALOPERIDOL DECANOATE.

MedlinePlus Drug Summary

Haloperidol injection and haloperidol extended-release injection are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Haloperidol injection is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in people who have Tourette's disorder (condition characterized by motor or verbal tics). Haloperidol is in a class of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

Related Packages: 72785-0007-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Haloperidol Injection

Product Information

NDC	72785-0007
Product ID	72785-0007_ed63a7e6-a769-4c05-8e33-d724debffa7e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Haloperidol decanoate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Haloperidol decanoate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION
Route	INTRAMUSCULAR
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	HALOPERIDOL DECANOATE
Labeler Name	Zydus Lifesciences Limited
Pharmaceutical Class	Typical Antipsychotic [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211180
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72785-0007-01 (72785000701)

Pricing Information	N/A
NDC Package Code	72785-0007-1
Billing NDC	72785000701
Package	1 VIAL, MULTI-DOSE in 1 CARTON (72785-0007-1) / 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date	2019-11-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9a6dde83-1c6f-48ca-9451-90b5f2c8689d Details

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

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)

Revised: 11/2022

Document Id: ed63a7e6-a769-4c05-8e33-d724debffa7e

Set id: 9a6dde83-1c6f-48ca-9451-90b5f2c8689d

Version: 3

Effective Time: 20221105

Search by Drug Name or NDC

NDC 72785-0007-01 Haloperidol decanoate 100 mg/mL Details

Haloperidol decanoate 100 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 72785-0007-01 (72785000701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9a6dde83-1c6f-48ca-9451-90b5f2c8689d Details

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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