Haloperidol

Product NDC: 67046-1603
Requested package NDC: 67046-1603-3
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…`

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

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 · 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 (package): 67046-1603-3 ndc (product): 67046-1603 ndc11 (package): 67046160303
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

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