Haloperidol decanoate

Product NDC: 68001-658
Requested package NDC: 68001-658-52
11-digit product format: 680010658
Labeler code: 68001
Product ID: 68001-658_5c8c085a-c1c8-831f-e063-6394a90a88bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol decanoate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: BluePoint Laboratories
Application: ANDA211180
Marketing category: ANDA
Marketing start: 2025-06-12
Substance: HALOPERIDOL DECANOATE
Active strength: 100 mg/mL
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Haloperidol decanoate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL DECANOATE	100 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d599bae4-cb25-0798-7468-31aa188fb750	Product name	7	20260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e	Product name	2	20250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0	Product name	3	20240202
ce329990-eb12-45a5-87d5-ce5ef054ca71	Product name	2	20190930
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68001-658-41	Haloperidol decanoate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	6
68001-658-41	Haloperidol decanoate	1 in 1 CARTON	INJECTION	1	6
68001-658-52	Haloperidol decanoate	5 in 1 CARTON	INJECTION	5	6
68001-658-52	Haloperidol decanoate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-658-41	ML - Milliliter	68001-658	4a0cfe71-6a4e-4569-bb43-1c36296ec7cb	1	2025-08-11
68001-658-52	ML - Milliliter	68001-658	7d5afbb2-5198-40c5-9025-fd32b99d487c	1	2025-08-11

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol decanoate	HALOPERIDOL DECANOATE	Zydus Pharmaceuticals USA Inc.	6d2d7612-ad47-4ee7-a42c-945c976d947b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211180 application number: ANDA211180
Haloperidol decanoate	HALOPERIDOL DECANOATE	BluePoint Laboratories	3d011250-a517-4c27-8ce3-d59d441ea61c	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211180 application number: ANDA211180 ndc (package): 68001-658-52 ndc (product): 68001-658 ndc11 (package): 68001065852
Haloperidol decanoate	HALOPERIDOL DECANOATE	Zydus Lifesciences Limited	d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9	2023-09-01		Exact identifier application applno (ANDA): 211180 application number: ANDA211180

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AC20PJ4101	HALOPERIDOL DECANOATE	74050-97-8	HALOPERIDOL DECANOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1719803	haloperidol decanoate 100 MG in 1 ML Injection	PSN	3d011250-a517-4c27-8ce3-d59d441ea61c	6
859871	haloperidol decanoate 100 MG/ML Injectable Solution	PSN	3d011250-a517-4c27-8ce3-d59d441ea61c	6
1719862	haloperidol decanoate 50 MG in 1 ML Injection	PSN	3d011250-a517-4c27-8ce3-d59d441ea61c	6
1719803	1 ML haloperidol decanoate 100 MG/ML Injection	SCD	3d011250-a517-4c27-8ce3-d59d441ea61c	6
1719862	1 ML haloperidol decanoate 50 MG/ML Injection	SCD	3d011250-a517-4c27-8ce3-d59d441ea61c	6
859871	haloperidol decanoate 100 MG/ML Injectable Solution	SCD	3d011250-a517-4c27-8ce3-d59d441ea61c	6
859871	haloperidol 100 MG/ML (as haloperidol decanoate) Injectable Solution	SY	3d011250-a517-4c27-8ce3-d59d441ea61c	6
1719803	haloperidol decanoate 100 MG per 1 ML Injection	SY	3d011250-a517-4c27-8ce3-d59d441ea61c	6
1719862	haloperidol decanoate 50 MG per 1 ML Injection	SY	3d011250-a517-4c27-8ce3-d59d441ea61c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68001-658-52	68001065852	5 VIAL, SINGLE-DOSE in 1 CARTON (68001-658-52) / 1 mL in 1 VIAL, SINGLE-DOSE	2025-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol decanoate	BluePoint Laboratories \| Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	7