Haloperidol

Product NDC: 67046-0838
11-digit product format: 670460838
Labeler code: 67046
Product ID: 67046-0838_509e5fd6-a61b-c9c1-e063-6294a90ac172
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA077580
Marketing category: ANDA
Marketing start: 2026-04-29
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
A077580-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17
A077580-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17
A077580-003	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29
A077580-004	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29
A077580-005	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29
A077580-006	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077580-001	AB
A077580-002	AB
A077580-003	AB
A077580-004	AB
A077580-005	AB
A077580-006	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 5 · 192 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	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB	2007-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	2023-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2023-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2023-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB	2007-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB	2007-11-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 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	A077580-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077580-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077580-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077580-004	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
509e5424-1323-c841-e063-6294a90a2714	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	Strength	SPL version
67046-0838-3	Haloperidol	30 in 1 BLISTER PACK	TABLET	30		1

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Coupler LLC	5827f1d4-ff98-03ba-e063-6394a90a4630	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	746f3ab9-9e6e-4ce8-9384-0c7a57de8007	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Unit Dose Solutions, Inc.	54ee5fa9-e346-a1d0-e063-6294a90aef83	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Safecor Health, LLC	9be08519-b3b5-4b9d-ae4c-bb7e68f19ede	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Coupler LLC	26aa869a-25e8-0dd5-e063-6394a90a0aba	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Coupler LLC	509e5424-1323-c841-e063-6294a90a2714	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580 ndc (product): 67046-0838
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	e07f02d4-2768-4978-97ee-23ac52d0b846	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	1e396020-899d-4f51-b71a-4982c503ca4f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	58fa9328-b1c7-407c-b215-9887db90cb94	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	American Health Packaging	0ac0cc44-3924-447d-9051-f84c44312380	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	American Health Packaging	d62617da-c8ad-45da-8915-c59edc5558a5	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Coupler LLC	315899f3-d510-10b0-e063-6294a90a2f3e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Zydus Lifesciences Limited	509d0eb2-b930-4836-9669-dbebf0ac4076	2024-11-30		Exact identifier application applno (ANDA): 077580 application number: ANDA077580
Haloperidol	HALOPERIDOL	Zydus Pharmaceuticals USA Inc.	54502f78-7244-454a-9171-4e73127f1456	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077580 application number: ANDA077580

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	509e5424-1323-c841-e063-6294a90a2714	1
314035	haloperidol 10 MG Oral Tablet	SCD	509e5424-1323-c841-e063-6294a90a2714	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-0838-3	67046083803	30 TABLET in 1 BLISTER PACK (67046-0838-3)	30 tablet	2026-04-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol Tablets, USP	Coupler LLC \| Zydus Pharmaceuticals USA Inc.	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	1