RISPERIDONE

Product NDC: 71205-520
11-digit product format: 712050520
Labeler code: 71205
Product ID: 71205-520_be1f8d5f-876a-4c16-b504-8812d781e06d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISPERIDONE
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA201003
Marketing category: ANDA
Marketing start: 2014-03-28
Substance: RISPERIDONE
Active strength: .25 mg/1
Pharmacologic classes: Atypical 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
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.

Additional Listing Data#

Finished product: Yes
Brand name base: RISPERIDONE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6UH7ZF8HC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312828	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
394c7e27-52a2-4d4c-8c6e-fe37b03266ae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-520-30	RISPERIDONE	30 in 1 BOTTLE	TABLET	30	2
71205-520-60	RISPERIDONE	60 in 1 BOTTLE	TABLET	60	2
71205-520-90	RISPERIDONE	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-520-30	EA - Each	71205-520	a94c28e7-2e4c-434b-a244-1423257b2f85	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-520	RISPERIDONE TABLET [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 3 package rows	20220626_394c7e27-52a2-4d4c-8c6e-fe37b03266ae.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 ndc (product): 71205-520
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	RISPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312828	risperiDONE 0.25 MG Oral Tablet	PSN	394c7e27-52a2-4d4c-8c6e-fe37b03266ae	2
312828	risperidone 0.25 MG Oral Tablet	SCD	394c7e27-52a2-4d4c-8c6e-fe37b03266ae	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-520-30	71205052030	30 TABLET in 1 BOTTLE (71205-520-30)	30 tablet	2021-01-05	0000-00-00	No	No	Current
71205-520-60	71205052060	60 TABLET in 1 BOTTLE (71205-520-60)	60 tablet	2021-01-05	0000-00-00	No	No	Current
71205-520-90	71205052090	90 TABLET in 1 BOTTLE (71205-520-90)	90 tablet	2021-01-05	0000-00-00	No	No	Current