Haloperidol

Product NDC: 0904-5923
11-digit product format: 009045923
Labeler code: 0904
Product ID: 0904-5923_68ba98b0-35b1-46af-b5e7-2763261a40c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA071207
Marketing category: ANDA
Marketing start: 2009-02-19
Marketing end: 0000-00-00
Substance: HALOPERIDOL
Active strength: 1 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0904-5923		D	Discontinued by firm		2026-08-11
excluded package	package	0904-5923	0904-5923-61	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5923-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5923-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5923-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5923-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5923-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5923-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5923-61	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5923-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5923-61	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5923-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5923-61	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5923-61	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
2022-04-04 05:41 UTC	2022-04	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A071207-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071207-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071207-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071207-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071207-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071207-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071207-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071207-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071207-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071207-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071207-001	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5923-61	EA - Each	0904-5923	fc4d87c2-1310-4d1d-9398-61ae10b2a549	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HALOPERIDOL	ACTIVE INGREDIENT	J6292F8L3D	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]	1

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
0904-5923-61	00904592361	100 TABLET in 1 BOX, UNIT-DOSE (0904-5923-61)	100 tablet	2009-02-19	0000-00-00	No	No	Current