Haloperidol

Product NDC: 53808-0414
11-digit product format: 538080414
Labeler code: 53808
Product ID: 53808-0414_ff1989ff-b72f-4071-b121-ed099cef0a9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA071208
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: HALOPERIDOL
Active strength: 2 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	53808-0414		I	Inactivated by FDA		2026-08-11
excluded package	package	53808-0414	53808-0414-1	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0414-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0414-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0414-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0414-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0414-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0414-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0414-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0414-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0414-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0414-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0414-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0414-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0414-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0414-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0414-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0414-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0414-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0414-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0414-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0414-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0414-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0414-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	Approval date	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071208-001	HALOPERIDOL	2MG	TABLET / ORAL	1986-11-17	`ea99ee380514…`

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
53808-0414-1	2020-01-31	C162847	48780-1	9d75b9d0-89b9-f424-e053-dadaa90a57ce	Haloperidol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0414-1	Haloperidol	30 in 1 BLISTER PACK	TABLET	30		2

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0414	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2	Legacy NDC, 1 package rows	20100813_df0f93db-aa16-4f30-8c49-904d269b36b1.zip

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
310671	haloperidol 1 MG Oral Tablet	PSN	df0f93db-aa16-4f30-8c49-904d269b36b1	2
314034	haloperidol 2 MG Oral Tablet	PSN	df0f93db-aa16-4f30-8c49-904d269b36b1	2
310672	haloperidol 5 MG Oral Tablet	PSN	df0f93db-aa16-4f30-8c49-904d269b36b1	2
310671	haloperidol 1 MG Oral Tablet	SCD	df0f93db-aa16-4f30-8c49-904d269b36b1	2
314034	haloperidol 2 MG Oral Tablet	SCD	df0f93db-aa16-4f30-8c49-904d269b36b1	2
310672	haloperidol 5 MG Oral Tablet	SCD	df0f93db-aa16-4f30-8c49-904d269b36b1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0414-1	53808041401	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol Tablets, USP	State of Florida DOH Central Pharmacy	2010-08-12	HUMAN PRESCRIPTION DRUG LABEL	2