Haloperidol

Product NDC: 70518-4725
Requested package NDC: 70518-4725-0
11-digit product format: 705184725
Labeler code: 70518
Product ID: 70518-4725_590115aa-2728-b742-e063-6394a90aa6af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA216918
Marketing category: ANDA
Marketing start: 2026-08-12
Substance: HALOPERIDOL
Active strength: 10 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
A216918-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11
A216918-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11
A216918-003	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11
A216918-004	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11
A216918-005	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11
A216918-006	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216918-001	AB
A216918-002	AB
A216918-003	AB
A216918-004	AB
A216918-005	AB
A216918-006	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 · 102 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	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-005	HALOPERIDOL	10MG	TABLET / ORAL	AB	2024-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-006	HALOPERIDOL	20MG	TABLET / ORAL	AB	2024-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	2024-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-002	HALOPERIDOL	1MG	TABLET / ORAL	AB	2024-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-003	HALOPERIDOL	2MG	TABLET / ORAL	AB	2024-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-004	HALOPERIDOL	5MG	TABLET / ORAL	AB	2024-04-11	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A216918-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216918-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216918-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216918-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216918-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216918-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216918-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216918-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216918-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216918-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216918-004	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	10 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
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
addb5b30-d1f8-47dd-ba4c-94d0b01ae17c	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	a0751f2e-05ab-4ba9-9bae-7b791bf1a621	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216918 application number: ANDA216918
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	addb5b30-d1f8-47dd-ba4c-94d0b01ae17c	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216918 application number: ANDA216918 ndc (package): 70518-4725-0 ndc (product): 70518-4725 ndc11 (package): 70518472500
Haloperidol	HALOPERIDOL	NCS HealthCare of KY, LLC dba Vangard Labs	8743da03-67f1-4cb0-8159-45141cb5466e	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216918 application number: ANDA216918
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	8a1014d0-d917-40b7-bddd-9ac97df91ef4	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216918 application number: ANDA216918
Haloperidol	HALOPERIDOL	Lifestar Pharma LLC	00bb61c8-db35-4c04-9ef7-47d447d2496b	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216918 application number: ANDA216918

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J6292F8L3D	HALOPERIDOL	52-86-8	HALOPERIDOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4725-0	70518472500	100 POUCH in 1 BOX (70518-4725-0) / 1 TABLET in 1 POUCH (70518-4725-1)	100 pouch	2026-08-12	No	No	Current