Haloperidol

Product NDC: 0378-0334
Requested package NDC: 0378-0334-01
11-digit product format: 003780334
Labeler code: 0378
Product ID: 0378-0334_1b33ae94-4fa5-4298-a713-3e049c47588c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA070278
Marketing category: ANDA
Marketing start: 2009-07-17
Marketing end: 2026-07-31
Substance: HALOPERIDOL
Active strength: 10 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-0334	0378-0334-01	D	Discontinued by firm		2026-08-03

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	RLD / RS	Approval date
A070278-001	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10
A070278-002	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB		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 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A070278-001	AB
A070278-002	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 · 246 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
2026-02-19 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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 241 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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070278-004	AB	1	`2680178bc6a6…`

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
0378-0334-01	Haloperidol	100 in 1 BOTTLE, PLASTIC	TABLET	100		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0334-01	EA - Each	0378-0334	ad77fb30-b313-48da-9a93-5ac7ab8d3c5f	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 PHARMACEUTICALS INC.]	11
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	11
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
HALOPERIDOL	ACTIVE INGREDIENT	J6292F8L3D	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.]	4
HALOPERIDOL	ACTIVE INGREDIENT	J6292F8L3D	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0334	HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]	21	Current NDC, Legacy NDC, 1 package rows	20250326_c559b0b0-4087-d12a-e718-c18ccb6811e6.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
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 ndc (package): 0378-0334-01 ndc (product): 0378-0334 ndc11 (package): 00378033401

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	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
310671	haloperidol 1 MG Oral Tablet	PSN	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
314035	haloperidol 10 MG Oral Tablet	PSN	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
314034	haloperidol 2 MG Oral Tablet	PSN	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
197754	haloperidol 20 MG Oral Tablet	PSN	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
310672	haloperidol 5 MG Oral Tablet	PSN	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
310670	haloperidol 0.5 MG Oral Tablet	SCD	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
310671	haloperidol 1 MG Oral Tablet	SCD	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
314035	haloperidol 10 MG Oral Tablet	SCD	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
314034	haloperidol 2 MG Oral Tablet	SCD	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
197754	haloperidol 20 MG Oral Tablet	SCD	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
310672	haloperidol 5 MG Oral Tablet	SCD	c559b0b0-4087-d12a-e718-c18ccb6811e6	22
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
310670	haloperidol 0.5 MG Oral Tablet	PSN	59903eb9-77a2-42b3-ae09-af94ac209d32	4
310671	haloperidol 1 MG Oral Tablet	PSN	59903eb9-77a2-42b3-ae09-af94ac209d32	4
314035	haloperidol 10 MG Oral Tablet	PSN	59903eb9-77a2-42b3-ae09-af94ac209d32	4
314034	haloperidol 2 MG Oral Tablet	PSN	59903eb9-77a2-42b3-ae09-af94ac209d32	4
197754	haloperidol 20 MG Oral Tablet	PSN	59903eb9-77a2-42b3-ae09-af94ac209d32	4
310672	haloperidol 5 MG Oral Tablet	PSN	59903eb9-77a2-42b3-ae09-af94ac209d32	4
310670	haloperidol 0.5 MG Oral Tablet	SCD	59903eb9-77a2-42b3-ae09-af94ac209d32	4
310671	haloperidol 1 MG Oral Tablet	SCD	59903eb9-77a2-42b3-ae09-af94ac209d32	4
314035	haloperidol 10 MG Oral Tablet	SCD	59903eb9-77a2-42b3-ae09-af94ac209d32	4
314034	haloperidol 2 MG Oral Tablet	SCD	59903eb9-77a2-42b3-ae09-af94ac209d32	4
197754	haloperidol 20 MG Oral Tablet	SCD	59903eb9-77a2-42b3-ae09-af94ac209d32	4
310672	haloperidol 5 MG Oral Tablet	SCD	59903eb9-77a2-42b3-ae09-af94ac209d32	4
314035	haloperidol 10 MG Oral Tablet	PSN	b9ba5d5c-f63a-4763-bd07-b43fc9f610ff	1
314034	haloperidol 2 MG Oral Tablet	PSN	b9ba5d5c-f63a-4763-bd07-b43fc9f610ff	1
314035	haloperidol 10 MG Oral Tablet	SCD	b9ba5d5c-f63a-4763-bd07-b43fc9f610ff	1
314034	haloperidol 2 MG Oral Tablet	SCD	b9ba5d5c-f63a-4763-bd07-b43fc9f610ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0334-01	00378033401	100 TABLET in 1 BOTTLE, PLASTIC (0378-0334-01)	100 tablet	2009-07-17	2026-07-31	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
Haloperidol Tablets, USP 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg and 20 mg	Mylan Pharmaceuticals Inc.	2025-01-15	HUMAN PRESCRIPTION DRUG LABEL	22
Haloperidol - REMEDYREPACK INC.	REMEDYREPACK INC.	2020-02-13	HUMAN PRESCRIPTION DRUG LABEL	4
Haloperidol - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2013-09-11	HUMAN PRESCRIPTION DRUG LABEL	1
Haloperidol - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-09-14	HUMAN PRESCRIPTION DRUG LABEL	4