Haloperidol

Product NDC: 51079-733
Requested package NDC: 51079-733-20
11-digit product format: 510790733
Labeler code: 51079
Product ID: 51079-733_3dd4fea4-d455-5a4d-e063-6394a90ab14c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA070278
Marketing category: ANDA
Marketing start: 2004-02-01
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 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
A070278-001	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	1986-06-10
A070278-002	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL		2009-07-16
A070278-003	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL		2009-07-16
A070278-004	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-06-10
A070278-005	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-06-10
A070278-006	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A070278-001	AB
A070278-004	AB
A070278-005	AB
A070278-006	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL			2009-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL			2009-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL			2009-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 250 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	A070278-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070278-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-001	AB	1	`03ed91905a0d…`

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: 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
ad7d2f17-a4e8-4ebc-9baf-5983ac626782	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
51079-733-01	Haloperidol	1 in 1 BLISTER PACK	TABLET	1		18
51079-733-20	Haloperidol	100 in 1 CARTON	TABLET	100		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-733-01	EA - Each	51079-733	6d476624-04e8-44bc-a43c-0ee34f758d96	1	2012-07-24
51079-733-20	EA - Each	51079-733	e210ec15-0c63-4049-b15b-9b97572edf8d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HALOPERIDOL	ACTIVE INGREDIENT	J6292F8L3D	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-733	HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]	16	Current NDC, Legacy NDC, 2 package rows	20211217_ad7d2f17-a4e8-4ebc-9baf-5983ac626782.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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	8ca14b79-6671-4e44-aa34-6564a92aa197	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Mylan Institutional Inc.	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278 ndc (package): 51079-733-20 ndc (product): 51079-733 ndc11 (package): 51079073320
Haloperidol	HALOPERIDOL	Coupler LLC	2ccc2e26-de98-af81-e063-6394a90a040b	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Mylan Pharmaceuticals Inc.	c559b0b0-4087-d12a-e718-c18ccb6811e6	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278

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	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
310671	haloperidol 1 MG Oral Tablet	PSN	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
314035	haloperidol 10 MG Oral Tablet	PSN	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
314034	haloperidol 2 MG Oral Tablet	PSN	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
310672	haloperidol 5 MG Oral Tablet	PSN	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
310670	haloperidol 0.5 MG Oral Tablet	SCD	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
310671	haloperidol 1 MG Oral Tablet	SCD	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
314035	haloperidol 10 MG Oral Tablet	SCD	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
314034	haloperidol 2 MG Oral Tablet	SCD	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18
310672	haloperidol 5 MG Oral Tablet	SCD	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-733-20	51079073320	100 BLISTER PACK in 1 CARTON (51079-733-20) / 1 TABLET in 1 BLISTER PACK (51079-733-01)	100 blister pack	2004-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	18