Risperidone

Product NDC: 70518-3741
11-digit product format: 705183741
Labeler code: 70518
Product ID: 70518-3741_4f81da24-3508-7699-e063-6394a90a3c19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: SOLUTION
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA079059
Marketing category: ANDA
Marketing start: 2023-06-01
Substance: RISPERIDONE
Active strength: 1 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079059-001	RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA		2012-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079059-001	AA

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 · 43 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	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2012-12-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A079059-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079059-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079059-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079059-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079059-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079059-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079059-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079059-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079059-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079059-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079059-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079059-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079059-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079059-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079059-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079059-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079059-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079059-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079059-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079059-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079059-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079059-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079059-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079059-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079059-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079059-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079059-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079059-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079059-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079059-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079059-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079059-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079059-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079059-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079059-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079059-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079059-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079059-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079059-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079059-001	AA	1	`f41ea6bd6efb…`

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	1 mg/mL

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
199387	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
8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3741-0	Risperidone	10 in 1 BOX	SOLUTION	10		5
70518-3741-1	Risperidone	2 mL in 1 CUP, UNIT-DOSE	SOLUTION	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3741	RISPERIDONE SOLUTION [REMEDYREPACK INC.]	3	Current NDC, 2 package rows	20240329_8a4158fe-37d4-4c97-9c44-1c3489fe2a9f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	ATLANTIC BIOLOGICALS CORP.	dc8c6638-f487-49df-a265-78caa93e43d8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059
Risperidone	RISPERIDONE	REMEDYREPACK INC.	8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059 ndc (product): 70518-3741
Risperidone	RISPERIDONE	Bryant Ranch Prepack	4604052d-dbda-4535-b7b8-1bd72a129aca	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059
Risperidone	RISPERIDONE	Cranbury Pharmaceuticals, LLC	a0a21bec-68f0-444e-a611-d0602859410c	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059
Risperidone	RISPERIDONE	Bryant Ranch Prepack	3cc027f0-3462-4a2f-925b-d8a529bcb3c3	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059

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
199387	risperiDONE 1 MG in 1 mL Oral Solution	PSN	8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	5
199387	risperidone 1 MG/ML Oral Solution	SCD	8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	5
199387	risperidone 1 MG per 1 ML Oral Solution	SY	8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3741-0	70518374100	10 CUP, UNIT-DOSE in 1 BOX (70518-3741-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3741-1)		2023-06-01	No	No	Current
70518-3741-1	70518374101	2 mL in 1 CUP, UNIT-DOSE	2 ml				Historical