Risperidone

Product NDC: 0480-1342
11-digit product format: 004801342
Labeler code: 0480
Product ID: 0480-1342_7cf4d36f-baab-4a9e-8a17-aeb0d6dd7918
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: KIT
Labeler: Teva Pharmaceuticals, Inc.
Application: ANDA214068
Marketing category: ANDA
Marketing start: 2023-12-11
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214068-001	RISPERIDONE	RISPERIDONE	12.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05
A214068-002	RISPERIDONE	RISPERIDONE	25MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05
A214068-003	RISPERIDONE	RISPERIDONE	37.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05
A214068-004	RISPERIDONE	RISPERIDONE	50MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214068-001	AB
A214068-002	AB
A214068-003	AB
A214068-004	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 2 · 68 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	A214068-001	RISPERIDONE	12.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214068-002	RISPERIDONE	25MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214068-003	RISPERIDONE	37.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214068-004	RISPERIDONE	50MG/VIAL	POWDER / INTRAMUSCULAR	AB	2023-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214068-001	RISPERIDONE	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214068-002	RISPERIDONE	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214068-003	RISPERIDONE	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214068-004	RISPERIDONE	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	2023-12-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A214068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214068-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214068-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214068-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214068-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214068-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214068-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214068-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214068-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214068-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214068-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214068-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214068-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214068-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214068-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214068-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214068-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Risperidone
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402010	Internal RxNorm lookup
402011	Internal RxNorm lookup
402012	Internal RxNorm lookup
706822	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
32c0f081-b418-4c1c-b39e-eb5c344043c7	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0480-1342-08	Risperidone	1 in 1 CARTON	KIT	1		3
0480-9734-01	Risperidone	2 mL in 1 VIAL	INJECTION, POWDER, FOR SUSPENSIO	2 mL	37.5 mg in 2mL	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0480-1342-08	EA - Each	0480-1342	22c485eb-f2aa-4751-8f56-20d72a14ff03	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0480-1342	RISPERIDONE KIT [TEVA PHARMACEUTICALS, INC.]	3	Current NDC, 2 package rows	20250402_32c0f081-b418-4c1c-b39e-eb5c344043c7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Teva Pharmaceuticals, Inc.	32c0f081-b418-4c1c-b39e-eb5c344043c7	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214068 application number: ANDA214068 ndc (product): 0480-1342

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
706822	risperiDONE 12.5 MG Extended Release Injection	PSN	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
402010	risperiDONE 25 MG Extended Release Injection	PSN	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
402011	risperiDONE 37.5 MG Extended Release Injection	PSN	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
402012	risperiDONE 50 MG Extended Release Injection	PSN	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
706822	risperidone 12.5 MG Injection	SCD	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
402010	risperidone 25 MG Injection	SCD	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
402011	risperidone 37.5 MG Injection	SCD	32c0f081-b418-4c1c-b39e-eb5c344043c7	3
402012	risperidone 50 MG Injection	SCD	32c0f081-b418-4c1c-b39e-eb5c344043c7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0480-1342-08	00480134208	1 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21)	1 kit	2023-12-11	No	No	Current
0480-9734-01	00480973401	2 mL in 1 VIAL	2 ml				Historical