risperidone

Product NDC: 55154-0180
11-digit product format: 551540180
Labeler code: 55154
Product ID: 55154-0180_85faf8ed-8e0d-451f-a2cb-06d73032703b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA078040
Marketing category: ANDA
Marketing start: 2025-05-19
Substance: RISPERIDONE
Active strength: .5 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 1.

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
A078040-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16
A078040-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16
A078040-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16
A078040-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16
A078040-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16
A078040-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078040-001	AB
A078040-002	AB
A078040-003	AB
A078040-004	AB
A078040-005	AB
A078040-006	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 · 246 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
2026-02-19 14:30 UTC	2026-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078040-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312829	Internal RxNorm lookup
312830	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
3ce21196-4aa0-469b-8f04-6650b2c48cb5	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	Strength	SPL version
55154-0180-0	risperidone	10 in 1 BAG	TABLET, FILM COATED	10		4
55154-0180-0	risperidone	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-0180	RISPERIDONE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	2	Current NDC, 2 package rows	20250523_3ce21196-4aa0-469b-8f04-6650b2c48cb5.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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
risperidone	RISPERIDONE	Cardinal Health 107, LLC	3ce21196-4aa0-469b-8f04-6650b2c48cb5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040 ndc (product): 55154-0180
risperidone	RISPERIDONE	Major Pharmaceuticals	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
Risperidone	RISPERIDONE	American Health Packaging	f11dae15-b057-4258-9229-3819d0c980fe	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Zydus Pharmaceuticals USA Inc.	713b5ac7-53d6-4139-8599-3028f789de4b	2025-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Zydus Lifesciences Limited	23993d21-80bf-41c4-b57d-88a620173b6b	2024-08-12		Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Proficient Rx LP	b611fe52-1787-47e6-8a6b-1999a4e4f22c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040

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
312829	risperiDONE 0.5 MG Oral Tablet	PSN	3ce21196-4aa0-469b-8f04-6650b2c48cb5	4
312830	risperiDONE 1 MG Oral Tablet	PSN	3ce21196-4aa0-469b-8f04-6650b2c48cb5	4
312829	risperidone 0.5 MG Oral Tablet	SCD	3ce21196-4aa0-469b-8f04-6650b2c48cb5	4
312830	risperidone 1 MG Oral Tablet	SCD	3ce21196-4aa0-469b-8f04-6650b2c48cb5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-0180-0	55154018000	10 BLISTER PACK in 1 BAG (55154-0180-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2025-05-19	No	No	Current