Risperidone

Product NDC: 17856-0673
11-digit product format: 178560673
Labeler code: 17856
Product ID: 17856-0673_11c32f49-4cb0-4ea0-8f96-49c48031ecb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: ANDA091384
Marketing category: ANDA
Marketing start: 2011-05-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0673		I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-1	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-2	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-3	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-6	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-7	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-8	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0673	17856-0673-9	I	Inactivated by FDA	2026-08-11

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 3 · 176 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0673-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0673-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0673-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0673-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0673-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0673-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0673-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0673-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0673-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0673-2	`ed331223b511…`	`672a5bd82f5f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091384-001	RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA		2011-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091384-001	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 · 41 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	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091384-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2011-05-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A091384-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091384-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091384-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091384-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091384-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091384-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091384-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091384-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091384-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091384-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091384-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091384-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091384-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091384-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091384-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091384-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091384-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091384-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091384-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091384-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091384-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091384-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091384-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091384-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091384-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091384-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091384-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091384-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091384-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091384-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091384-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091384-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091384-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091384-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091384-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091384-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091384-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091384-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091384-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091384-001	AA	1	`cb3db0bc1861…`

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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
17856-0673-1	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993
17856-0673-2	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993
17856-0673-3	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993
17856-0673-6	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993
17856-0673-7	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993
17856-0673-8	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993
17856-0673-9	These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0673-1	Risperidone	1 mL in 1 SYRINGE	SOLUTION	1	6
17856-0673-1	Risperidone	120 in 1 BOX	SOLUTION	120	6
17856-0673-2	Risperidone	120 in 1 BOX	SOLUTION	120	6
17856-0673-2	Risperidone	2 mL in 1 SYRINGE	SOLUTION	2	6
17856-0673-3	Risperidone	120 in 1 BOX	SOLUTION	120	6
17856-0673-3	Risperidone	3 mL in 1 SYRINGE	SOLUTION	3	6
17856-0673-6	Risperidone	48 in 1 CASE	SOLUTION	48	6
17856-0673-6	Risperidone	1 mL in 1 SYRINGE, PLASTIC	SOLUTION	1	6
17856-0673-7	Risperidone	48 in 1 CASE	SOLUTION	48	6
17856-0673-7	Risperidone	2 mL in 1 SYRINGE, PLASTIC	SOLUTION	2	6
17856-0673-8	Risperidone	48 in 1 CASE	SOLUTION	48	6
17856-0673-8	Risperidone	3 mL in 1 SYRINGE, PLASTIC	SOLUTION	3	6
17856-0673-9	Risperidone	4 mL in 1 SYRINGE, PLASTIC	SOLUTION	4	6
17856-0673-9	Risperidone	48 in 1 CASE	SOLUTION	48	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0673-1	ML - Milliliter	17856-0673	2d30bb99-2897-40aa-82de-dbca878b08cf	1	2016-12-07
17856-0673-2	ML - Milliliter	17856-0673	64964eb8-a6a8-4238-bd0c-f1613e0132c1	1	2016-12-07
17856-0673-3	ML - Milliliter	17856-0673	081115df-2888-4e2d-b418-c72a4ba71f87	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0673	RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	6	Legacy NDC, 14 package rows	20170514_3c9836aa-81cc-4759-a5e9-bb061bbbacc2.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	Amneal Pharmaceuticals LLC	bc55f60a-8121-44bb-bdfc-1d311879ba4f	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091384 application number: ANDA091384

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	3c9836aa-81cc-4759-a5e9-bb061bbbacc2	6
199387	risperidone 1 MG/ML Oral Solution	SCD	3c9836aa-81cc-4759-a5e9-bb061bbbacc2	6
199387	risperidone 1 MG per 1 ML Oral Solution	SY	3c9836aa-81cc-4759-a5e9-bb061bbbacc2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-0673-1	17856067301	1 mL in 1 SYRINGE	1 ml	Historical
17856-0673-2	17856067302	120 in 1 BOX		Historical
17856-0673-3	17856067303	120 in 1 BOX		Historical
17856-0673-6	17856067306	48 in 1 CASE		Historical
17856-0673-7	17856067307	48 in 1 CASE		Historical
17856-0673-8	17856067308	48 in 1 CASE		Historical
17856-0673-9	17856067309	4 mL in 1 SYRINGE, PLASTIC	4 ml	Historical