Risperidone

Product NDC: 67046-2064
Requested package NDC: 67046-2064-3
11-digit product format: 670462064
Labeler code: 67046
Product ID: 67046-2064_55f3f58c-a755-25de-e063-6394a90a0644
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA077493
Marketing category: ANDA
Marketing start: 2026-07-06
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
A077493-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29
A077493-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29
A077493-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29
A077493-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29
A077493-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29
A077493-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077493-001	AB
A077493-002	AB
A077493-003	AB
A077493-004	AB
A077493-005	AB
A077493-006	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	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`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	A077493-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077493-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077493-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077493-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077493-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	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
55f3ebec-a742-48fc-e063-6394a90a1452	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Coupler LLC	55f3ebec-a742-48fc-e063-6394a90a1452	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493 ndc (package): 67046-2064-3 ndc (product): 67046-2064 ndc11 (package): 67046206403
Risperidone	RISPERIDONE	REMEDYREPACK INC.	c84807bd-35d7-4138-8989-42617d69293a	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Solco Healthcare US, LLC	43aa2a4f-1123-4f86-800b-9218882f7bcd	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NuCare Pharmaceuticals, Inc.	390904c2-fcfa-466e-e063-6394a90a03af	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Bryant Ranch Prepack	684dcda4-d270-400c-9798-7d920a038bbb	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	7bbc37f1-6d6a-4021-8976-1f103ce1cfbd	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	58e422ec-da66-41b0-83c1-aefd940beda0	2019-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-2064-3	67046206403	30 TABLET in 1 BLISTER PACK (67046-2064-3)	30 tablet	2026-07-06	No	No	Current