Haloperidol Decanoate Injection For Intramuscular Injection Only Rx only

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-11-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:49:30

Label at a glance#

ProductHaloperidol decanoate

Active ingredientHALOPERIDOL DECANOATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.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)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Haloperidol decanoate
HALOPERIDOL
SESAME OIL
BENZYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72785-0004	72785-0004-1, 72785-0004-6, 72785-0004-9
72785-0005	72785-0005-1, 72785-0005-5
72785-0006	72785-0006-1, 72785-0006-5
72785-0007	72785-0007-1, 72785-0007-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HALOPERIDOL DECANOATE	AC20PJ4101	ACTIM
SESAME OIL	QX10HYY4QV	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
HALOPERIDOL DECANOATE	AC20PJ4101	ACTIM
SESAME OIL	QX10HYY4QV	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
HALOPERIDOL DECANOATE	AC20PJ4101	ACTIM
SESAME OIL	QX10HYY4QV	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
HALOPERIDOL DECANOATE	AC20PJ4101	ACTIM
SESAME OIL	QX10HYY4QV	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211180-001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO		2019-10-22
A211180-002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO		2019-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211180-001	AO
A211180-002	AO

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211180-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211180-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2019-10-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211180-001	AO	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211180-002	AO	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211180-001	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211180-002	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211180-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211180-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211180-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211180-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211180-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211180-002	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211180-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211180-002	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211180-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211180-002	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211180-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211180-002	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211180-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211180-002	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211180-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211180-002	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211180-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211180-002	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211180-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211180-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211180-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211180-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211180-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211180-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211180-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211180-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211180-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211180-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211180-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211180-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211180-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211180-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211180-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211180-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211180-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211180-002	AO	1	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
12247dbf-8d03-401d-83ff-12f18dd94bc6			9a6dde83-1c6f-48ca-9451-90b5f2c8689d	2023-09-01		Exact identifier spl set id: 9a6dde83-1c6f-48ca-9451-90b5f2c8689d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.