HALOPERIDOL

Product NDC: 51662-1524
Requested package NDC: 51662-1524-1
11-digit product format: 516621524
Labeler code: 51662
Product ID: 51662-1524_beb6d1cf-98dc-d0a5-e053-2995a90ace90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol Lactate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA075689
Marketing category: ANDA
Marketing start: 2021-03-29
Substance: HALOPERIDOL LACTATE
Active strength: 5 mg/mL
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075689-001	HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2001-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075689-001	AP

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 2 · 43 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	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075689-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2001-03-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A075689-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075689-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075689-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075689-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075689-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075689-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075689-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075689-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075689-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075689-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075689-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075689-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075689-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075689-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075689-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075689-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075689-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075689-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075689-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075689-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075689-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075689-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075689-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075689-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075689-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075689-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075689-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075689-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075689-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075689-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075689-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075689-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075689-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075689-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075689-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075689-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075689-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075689-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075689-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075689-001	AP	1	`f41ea6bd6efb…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL LACTATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6387S86PK3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1719646	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
beb6d1cf-98db-d0a5-e053-2995a90ace90	Available on FDA.report

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
ce329990-eb12-45a5-87d5-ce5ef054ca71	Product name	2	20190930
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1524-1	HALOPERIDOL	1 mL in 1 VIAL	INJECTION, SOLUTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1524	HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	1	Current NDC, Legacy NDC, 1 package rows	20210331_beb6d1cf-98db-d0a5-e053-2995a90ace90.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	e2eed126-cb82-42b1-9b48-9cbeb6873b50	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075689 application number: ANDA075689
Haloperidol	HALOPERIDOL LACTATE	REMEDYREPACK INC.	e702b2f0-d464-41c3-977a-d37bb22c0ab0	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075689 application number: ANDA075689
Haloperidol	HALOPERIDOL LACTATE	Fresenius Kabi USA, LLC	b1ad2abd-a9d6-44e3-957b-36a73260f4f5	2022-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075689 application number: ANDA075689
HALOPERIDOL	HALOPERIDOL LACTATE	HF Acquisition Co LLC, DBA HealthFirst	beb6d1cf-98db-d0a5-e053-2995a90ace90	2021-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075689 application number: ANDA075689 ndc (package): 51662-1524-1 ndc (product): 51662-1524 ndc11 (package): 51662152401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6387S86PK3	HALOPERIDOL LACTATE	53515-91-6	HALOPERIDOL LACTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1719646	haloperidol 5 MG in 1 ML Injection	PSN	beb6d1cf-98db-d0a5-e053-2995a90ace90	1
1719646	1 ML haloperidol 5 MG/ML Injection	SCD	beb6d1cf-98db-d0a5-e053-2995a90ace90	1
1719646	haloperidol (as haloperidol lactate) 5 MG per 1 ML Injection	SY	beb6d1cf-98db-d0a5-e053-2995a90ace90	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1524-1	51662152401	1 mL in 1 VIAL (51662-1524-1)	1 ml	2021-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALOPERIDOL INJECTION, USP (FOR IMMEDIATE RELEASE) 5 mg PER mL 1mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2021-03-29	HUMAN PRESCRIPTION DRUG LABEL	1