HALOPERIDOL

Product NDC: 35573-441
11-digit product format: 355730441
Labeler code: 35573
Product ID: 35573-441_fdc7985f-5873-458b-9103-6ec550164e40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HALOPERIDOL
Dosage form: TABLET
Route: ORAL
Labeler: Burel Pharmaceuticals, LLC
Application: ANDA071131
Marketing category: ANDA
Marketing start: 2021-05-31
Marketing end: 0000-00-00
Substance: HALOPERIDOL
Active strength: 5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	35573-441		D	Discontinued by firm		2026-08-10
excluded package	package	35573-441	35573-441-02	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL		1987-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071131-001	HALOPERIDOL	5MG	TABLET / ORAL	AB	1987-02-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A071131-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071131-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071131-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071131-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A071131-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071131-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071131-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071131-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071131-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071131-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071131-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071131-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071131-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071131-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071131-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071131-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071131-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071131-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071131-001	AB	1	`cb3db0bc1861…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-441-02	EA - Each	35573-441	39cedc13-b3e4-410a-8817-c857d5c9b9d0	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35573-441	HALOPERIDOL TABLET [BUREL PHARMACEUTICALS, LLC]	7	Legacy NDC	20210606_7a71f18a-3a8c-4adb-8adf-660fcd8bf9b3.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35573-441-02	35573044102	100 TABLET in 1 BOTTLE (35573-441-02)	100 tablet	2021-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol Tablets, USP	Burel Pharmaceuticals, LLC \| Cycle Pharmaceuticals Ltd. \| Rubicon Research Limited	2021-04-01	HUMAN PRESCRIPTION DRUG LABEL	10