Haloperidol

Product NDC: 50090-4400
Requested package NDC: 50090-4400-0
11-digit product format: 500904400
Labeler code: 50090
Product ID: 50090-4400_f9692cbb-611b-43ab-ac4d-8a16cf0ebd43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA070278
Marketing category: ANDA
Marketing start: 1986-06-10
Marketing end: 0000-00-00
Substance: HALOPERIDOL
Active strength: 2 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4400	50090-4400-0	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070278-001	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	1986-06-10
A070278-002	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL		2009-07-16
A070278-003	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL		2009-07-16
A070278-004	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-06-10
A070278-005	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-06-10
A070278-006	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A070278-001	AB
A070278-004	AB
A070278-005	AB
A070278-006	AB

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL			2009-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL			2009-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL			2009-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 250 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	A070278-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070278-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-001	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4400-0	2023-01-30	C162847	48780-1	f386c649-b48a-0266-e053-dadaa90a7c1a	b03bc337-6068-4049-8113-660e99a88172

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4400-0	Haloperidol	33 in 1 BOTTLE	TABLET	33		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4400	HALOPERIDOL TABLET [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20210615_b03bc337-6068-4049-8113-660e99a88172.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	Cardinal Health 107, LLC	8ca14b79-6671-4e44-aa34-6564a92aa197	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Mylan Institutional Inc.	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Coupler LLC	2ccc2e26-de98-af81-e063-6394a90a040b	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Mylan Pharmaceuticals Inc.	c559b0b0-4087-d12a-e718-c18ccb6811e6	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J6292F8L3D	HALOPERIDOL	52-86-8	HALOPERIDOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314034	haloperidol 2 MG Oral Tablet	PSN	b03bc337-6068-4049-8113-660e99a88172	4
314034	haloperidol 2 MG Oral Tablet	SCD	b03bc337-6068-4049-8113-660e99a88172	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4400-0	50090440000	33 TABLET in 1 BOTTLE (50090-4400-0)	33 tablet	2019-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol - A-S Medication Solutions	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	4