Haloperidol

Product NDC: 71247-151
11-digit product format: 712470151
Labeler code: 71247
Product ID: 71247-151_ef4d587e-1e3e-4dbd-82f8-b102ec30df12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Innogenix, Inc.
Application: ANDA071173
Marketing category: ANDA
Marketing start: 2021-02-18
Substance: HALOPERIDOL
Active strength: 1 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 43.

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 · 258 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
2026-09-14 22:38:34	2026-08	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071173-001	HALOPERIDOL	10MG	TABLET / ORAL	AB	1988-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-002	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1987-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-003	HALOPERIDOL	1MG	TABLET / ORAL	AB	1987-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-004	HALOPERIDOL	2MG	TABLET / ORAL	AB	1987-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-005	HALOPERIDOL	5MG	TABLET / ORAL	AB	1988-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	1988-01-07	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071173-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071173-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071173-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071173-006	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL	1 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197754	Internal RxNorm lookup
310670	Internal RxNorm lookup
310671	Internal RxNorm lookup
310672	Internal RxNorm lookup
314034	Internal RxNorm lookup
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
2c26af24-5ed3-4eb7-8d29-d6a019320a70	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
71247-151-01	Haloperidol	100 in 1 BOTTLE	TABLET	100		4
71247-151-10	Haloperidol	1000 in 1 BOTTLE	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71247-151-01	EA - Each	71247-151	afc088b1-a8b7-464d-a3e6-8ba944f6c711	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71247-151	HALOPERIDOL TABLET [INNOGENIX, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20230113_2c26af24-5ed3-4eb7-8d29-d6a019320a70.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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	f1c56d0d-87d3-40ef-9578-0d99fbae12fe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	88031df0-90bd-4444-9503-1b4612e3856b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	b9e8f5f2-6d59-4a2c-8ccf-88bb58753f60	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	a8e9d675-135c-4b5d-91d0-1ef0d295535c	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	f20769bc-98a3-419a-ba36-2e9737050cd9	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	33dca652-c60c-44e0-9303-ea55a431fdcd	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	c3b35c6c-e339-439a-b75f-dd645e08a959	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	1171bd60-7105-4b70-a24c-f2bc8c52a8c0	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	a79c12f2-cf98-4337-8b6a-7b9ef2afa9d5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071173 application number: ANDA071173
Haloperidol	HALOPERIDOL	Amici Pharmaceuticals, LLC	9a9e20dd-646a-4fe9-a345-1b5bda8e7775	2022-05-02	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
310670	haloperidol 0.5 MG Oral Tablet	PSN	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
310671	haloperidol 1 MG Oral Tablet	PSN	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
314035	haloperidol 10 MG Oral Tablet	PSN	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
314034	haloperidol 2 MG Oral Tablet	PSN	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
197754	haloperidol 20 MG Oral Tablet	PSN	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
310672	haloperidol 5 MG Oral Tablet	PSN	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
310670	haloperidol 0.5 MG Oral Tablet	SCD	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
310671	haloperidol 1 MG Oral Tablet	SCD	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
314035	haloperidol 10 MG Oral Tablet	SCD	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
314034	haloperidol 2 MG Oral Tablet	SCD	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
197754	haloperidol 20 MG Oral Tablet	SCD	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4
310672	haloperidol 5 MG Oral Tablet	SCD	2c26af24-5ed3-4eb7-8d29-d6a019320a70	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71247-151-01	71247015101	100 TABLET in 1 BOTTLE (71247-151-01)	100 tablet	2021-02-18	0000-00-00	No	No	Current
71247-151-10	71247015110	1000 TABLET in 1 BOTTLE (71247-151-10)	1000 tablet	2021-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALOPERIDOL TABLETS, USP Rx only	Innogenix, Inc. \| Innogenix, LLC	2026-01-06	Human Prescription Drug Label	4
HALOPERIDOL TABLETS, USP Rx only	Major Pharmaceuticals	2022-08-09	HUMAN PRESCRIPTION DRUG LABEL	1