RISPERIDONE

Product NDC: 70518-1631
11-digit product format: 705181631
Labeler code: 70518
Product ID: 70518-1631_95691b69-2e2f-4c72-e053-2995a90a48af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISPERIDONE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA201003
Marketing category: ANDA
Marketing start: 2018-11-05
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-1631		D	Discontinued by firm		2026-10-12
excluded package	package	70518-1631	70518-1631-0	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1631-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1631-0	`0efc9e666f02…`	`f202fb6c5f17…`

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
A201003-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24
A201003-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24
A201003-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24
A201003-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24
A201003-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24
A201003-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201003-001	AB
A201003-002	AB
A201003-003	AB
A201003-004	AB
A201003-005	AB
A201003-006	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	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A201003-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201003-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201003-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1631	RISPERIDONE TABLET [REMEDYREPACK INC.]	9	Legacy NDC	20250124_f789b6a8-831b-470a-8a66-e85e687da724.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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Proficient Rx LP	2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Proficient Rx LP	088dc3dd-7740-471b-8c06-5a47900ae5b5	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Proficient Rx LP	1b5c9889-4dc3-48df-8629-4ac099e2b4c0	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Proficient Rx LP	394c7e27-52a2-4d4c-8c6e-fe37b03266ae	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ac152803-d75f-4c3c-bc49-8663b21a3a82	2019-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003