Haloperidol

Product NDC: 67046-1603
11-digit product format: 670461603
Labeler code: 67046
Product ID: 67046-1603_40187e11-e94a-e759-e063-6394a90a4840
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA218789
Marketing category: ANDA
Marketing start: 2025-10-01
Substance: HALOPERIDOL
Active strength: 5 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A218789-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19
A218789-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19
A218789-003	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19
A218789-004	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19
A218789-005	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19
A218789-006	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218789-001	AB
A218789-002	AB
A218789-003	AB
A218789-004	AB
A218789-005	AB
A218789-006	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 3 · 90 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	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-19	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 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	A218789-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218789-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218789-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218789-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218789-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218789-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218789-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218789-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218789-004	AB	1	`2680178bc6a6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Coupler LLC	50b0ea2f-0a54-7b49-e063-6394a90abcc4	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218789 application number: ANDA218789
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	ea01b32e-5abe-455d-8813-cef101fa53f1	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218789 application number: ANDA218789
Haloperidol	HALOPERIDOL	Coupler LLC	40187e83-1144-db0e-e063-6394a90a42df	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218789 application number: ANDA218789 ndc (product): 67046-1603
Haloperidol	HALOPERIDOL	Coupler LLC	325d169d-310d-4ada-e063-6294a90afbdd	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218789 application number: ANDA218789
Haloperidol	HALOPERIDOL	Coupler LLC	2ccbc964-a95c-d820-e063-6394a90a4307	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218789 application number: ANDA218789
Haloperidol	HALOPERIDOL	Aurobindo Pharma Limited	bf21633e-f37b-4017-a143-538eb005de2d	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218789 application number: ANDA218789

Additional Listing Data#

Finished product: Yes
Brand name base: Haloperidol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL	5 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
310672	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
40187e83-1144-db0e-e063-6394a90a42df	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
67046-1603-3	Haloperidol	30 in 1 BLISTER PACK	TABLET	30		1

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
310672	haloperidol 5 MG Oral Tablet	PSN	40187e83-1144-db0e-e063-6394a90a42df	1
310672	haloperidol 5 MG Oral Tablet	SCD	40187e83-1144-db0e-e063-6394a90a42df	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1603-3	67046160303	30 TABLET in 1 BLISTER PACK (67046-1603-3)	30 tablet	2025-10-01	No	No	Current