HALOPERIDOL

Product NDC: 82619-110
11-digit product format: 826190110
Labeler code: 82619
Product ID: 82619-110_46d58435-0437-e206-e063-6294a90ae755
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Creekwood Pharmaceuticals LLC
Application: ANDA218162
Marketing category: ANDA
Marketing start: 2026-01-05
Substance: HALOPERIDOL
Active strength: 20 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
A218162-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2025-12-18
A218162-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	2025-12-18
A218162-003	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	2025-12-18
A218162-004	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	2025-12-18
A218162-005	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB	2025-12-18
A218162-006	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB	2025-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218162-001	AB
A218162-002	AB
A218162-003	AB
A218162-004	AB
A218162-005	AB
A218162-006	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.

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	A218162-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2025-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2025-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2025-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2025-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2025-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2025-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218162-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2025-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2025-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2025-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2025-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2025-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2025-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218162-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2025-12-18	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2025-12-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2025-12-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2025-12-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2025-12-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2025-12-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2025-12-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218162-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218162-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218162-006	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218162-006	AB	1	`a50c72e98297…`

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	20 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
9763c044-7430-48f7-bf3e-da1c7c683955	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
82619-110-01	HALOPERIDOL	30 in 1 BOTTLE	TABLET	30		1
82619-110-02	HALOPERIDOL	100 in 1 BOTTLE	TABLET	100		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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	57d77858-758c-41ce-a47c-ca42c4e88859	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	f6f6f2ed-33a5-4139-b2f1-ce446814e597	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7666e56f-9eef-4343-8a76-60613c4ca57f	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	f6fb9e4c-630b-4f82-8223-f154dd6c17a2	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	42549018-8f15-40b4-ac0a-8b06a2178e46	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7212f03f-caa0-43bc-aac5-9d8b3c304897	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162
HALOPERIDOL	HALOPERIDOL	Creekwood Pharmaceuticals LLC	9763c044-7430-48f7-bf3e-da1c7c683955	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218162 application number: ANDA218162 ndc (product): 82619-110

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
197754	haloperidol 20 MG Oral Tablet	PSN	7666e56f-9eef-4343-8a76-60613c4ca57f	100
197754	haloperidol 20 MG Oral Tablet	SCD	7666e56f-9eef-4343-8a76-60613c4ca57f	100
310670	haloperidol 0.5 MG Oral Tablet	PSN	9763c044-7430-48f7-bf3e-da1c7c683955	1
310671	haloperidol 1 MG Oral Tablet	PSN	9763c044-7430-48f7-bf3e-da1c7c683955	1
314035	haloperidol 10 MG Oral Tablet	PSN	9763c044-7430-48f7-bf3e-da1c7c683955	1
314034	haloperidol 2 MG Oral Tablet	PSN	9763c044-7430-48f7-bf3e-da1c7c683955	1
197754	haloperidol 20 MG Oral Tablet	PSN	9763c044-7430-48f7-bf3e-da1c7c683955	1
310672	haloperidol 5 MG Oral Tablet	PSN	9763c044-7430-48f7-bf3e-da1c7c683955	1
310670	haloperidol 0.5 MG Oral Tablet	SCD	9763c044-7430-48f7-bf3e-da1c7c683955	1
310671	haloperidol 1 MG Oral Tablet	SCD	9763c044-7430-48f7-bf3e-da1c7c683955	1
314035	haloperidol 10 MG Oral Tablet	SCD	9763c044-7430-48f7-bf3e-da1c7c683955	1
314034	haloperidol 2 MG Oral Tablet	SCD	9763c044-7430-48f7-bf3e-da1c7c683955	1
197754	haloperidol 20 MG Oral Tablet	SCD	9763c044-7430-48f7-bf3e-da1c7c683955	1
310672	haloperidol 5 MG Oral Tablet	SCD	9763c044-7430-48f7-bf3e-da1c7c683955	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82619-110-01	82619011001	30 TABLET in 1 BOTTLE (82619-110-01)	30 tablet	2026-01-05	No	No	Current
82619-110-02	82619011002	100 TABLET in 1 BOTTLE (82619-110-02)	100 tablet	2026-01-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol Tablets, USP 0.5 mg, 1 mg, 2 mg, 10 mg and 20 mg Rx only	Bryant Ranch Prepack	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	100
Haloperidol Tablets, USP 0.5 mg, 1 mg, 2 mg, 10 mg and 20 mg Rx only	Creekwood Pharmaceuticals LLC \| V-Ensure Pharma Technologies Pvt. Ltd.	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	1