Risperidone

Product NDC: 55111-579
11-digit product format: 551110579
Labeler code: 55111
Product ID: 55111-579_38aae1c5-bc93-a425-927b-d976faf90bb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: SOLUTION
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA078909
Marketing category: ANDA
Marketing start: 2009-07-29
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 1 mg/mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55111-579		I	Inactivated by FDA		2026-10-05
excluded package	package	55111-579	55111-579-30	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-579-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-579-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-579-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-579-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-579-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-579-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-579-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-579-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-579-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-579-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55111-579-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55111-579-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55111-579-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55111-579-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55111-579-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55111-579-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55111-579-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55111-579-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55111-579-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55111-579-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55111-579-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55111-579-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A078909-001	RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA		2009-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078909-001	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	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078909-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-07-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078909-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078909-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078909-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078909-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078909-001	AA	1	`6a471c1ec25d…`
2019-09-15 20:21 UTC	2019-09	A078909-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078909-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078909-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55111-579-30	2020-01-31	C162847	48780-1	9d75b9d1-0861-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55111-579-30	Risperidone	30 mL in 1 BOTTLE	SOLUTION	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-579-30	ML - Milliliter	55111-579	d0267487-ecf3-49c1-910f-24e4169c2bd8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9
sorbitol	INACTIVE INGREDIENT	506T60A25R	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9
tartaric acid	INACTIVE INGREDIENT	W4888I119H	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9
water	INACTIVE INGREDIENT	059QF0KO0R	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-579	RISPERIDONE SOLUTION [DR. REDDY'S LABORATORIES LIMITED]	9	Legacy NDC, 1 package rows	20120307_b939e746-6b5f-ae82-c5f4-79cfdf6253ea.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	APOZEAL PHARMACEUTICALS INC	4ab6d256-6590-45be-a5df-f505987f96c3	2026-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078909 application number: ANDA078909

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	b939e746-6b5f-ae82-c5f4-79cfdf6253ea	9
199387	risperidone 1 MG/ML Oral Solution	SCD	b939e746-6b5f-ae82-c5f4-79cfdf6253ea	9
199387	risperidone 1 MG per 1 ML Oral Solution	SY	b939e746-6b5f-ae82-c5f4-79cfdf6253ea	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55111-579-30	55111057930	30 mL in 1 BOTTLE	30 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Dr. Reddy's Laboratories Limited \| Bio-Pharm, Inc.	2011-11-05	HUMAN PRESCRIPTION DRUG LABEL	9