Haloperidol

Product NDC: 70518-3587
11-digit product format: 705183587
Labeler code: 70518
Product ID: 70518-3587_4f5bc1f8-5ae6-94f0-e063-6294a90ae5f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA071173
Marketing category: ANDA
Marketing start: 2022-12-05
Substance: HALOPERIDOL
Active strength: 10 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A071173-001	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07
A071173-002	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02
A071173-003	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02
A071173-004	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02
A071173-005	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07
A071173-006	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A071173-001	AB
A071173-002	AB
A071173-003	AB
A071173-004	AB
A071173-005	AB
A071173-006	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 · 246 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
2026-02-19 14:30 UTC	2026-02	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071173-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071173-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071173-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071173-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071173-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071173-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071173-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071173-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071173-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Haloperidol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J6292F8L3D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314035	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
a3afd19a-c340-4fad-8ddd-d71242515345	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
ce329990-eb12-45a5-87d5-ce5ef054ca71	Product name	2	20190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3587-0	Haloperidol	30 in 1 BLISTER PACK	TABLET	30	6
70518-3587-1	Haloperidol	100 in 1 BOX	TABLET	100	6
70518-3587-2	Haloperidol	1 in 1 POUCH	TABLET	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3587	HALOPERIDOL TABLET [REMEDYREPACK INC.]	3	Current NDC, Legacy NDC, 3 package rows	20240116_a3afd19a-c340-4fad-8ddd-d71242515345.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	861c7b75-572c-48c2-adf9-1ca3fc3db19b	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	a3afd19a-c340-4fad-8ddd-d71242515345	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173 ndc (product): 70518-3587
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	22598f07-501b-471a-b512-449d95e2301c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	051f3c99-7d16-4185-a857-c90440e1b1c5	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	eb69959d-5967-41ac-a222-ff4416869dfc	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	b5a6c54c-fb70-4132-90ae-7d75b5e9c9de	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Innogenix, Inc.	2c26af24-5ed3-4eb7-8d29-d6a019320a70	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	966db55f-3f12-4653-9668-1beff85df0ab	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	5f4d945e-97f0-4afc-88d6-9b55ec238686	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	9353117e-bd01-441a-b35f-fd1352c5df8c	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	457b8b71-8acf-47f1-93e5-1d353e53af10	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	2cffe2ad-3dad-479e-a91a-b41c3dd05ce1	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Coupler LLC	38f59751-4741-f588-e063-6294a90a6528	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Method Pharmaceuticals, LLC	87f8773b-bf89-4f7e-bff4-8cad117d5776	2025-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	490efba9-70f1-46b8-9d62-2f96163e25df	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	e8977803-08a2-4ad0-87d5-63d81c98a536	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Marlex Pharmaceuticals, Inc.	e7a61604-741f-2d3b-e053-2995a90a62fc	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	d9d0e530-02cd-4631-b3c8-cf6de521fd5b	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	df340d75-7387-4084-9d76-167283ee7462	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	d896823a-fb08-4777-a1f1-cef85fc8d96c	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173

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
314035	haloperidol 10 MG Oral Tablet	PSN	a3afd19a-c340-4fad-8ddd-d71242515345	6
314035	haloperidol 10 MG Oral Tablet	SCD	a3afd19a-c340-4fad-8ddd-d71242515345	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3587-0	70518358700	30 TABLET in 1 BLISTER PACK (70518-3587-0)	30 tablet	2022-12-05	0000-00-00	No	No	Current
70518-3587-1	70518358701	100 POUCH in 1 BOX (70518-3587-1) / 1 TABLET in 1 POUCH (70518-3587-2)	100 pouch	2026-01-05		No	No	Current
70518-3587-2	70518358702	1 in 1 POUCH						Historical