FDA.reportPublic FDA data

Risperidone

Product NDC
17856-0063
Requested package NDC
17856-0063-4
11-digit product format
178560063
Labeler code
17856
Product ID
17856-0063_5e1431f2-90ae-4d5d-adf8-952a251a4fa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA076904
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
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-006317856-0063-4DDiscontinued by firm2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076904-001RISPERIDONERISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076904-001RISPERIDONE1MG/MLSOLUTION / ORAL2009-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076904-001RISPERIDONE1MG/MLSOLUTION / ORALAA2009-07-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076904-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076904-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076904-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076904-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076904-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076904-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076904-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A076904-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076904-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076904-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076904-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A076904-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076904-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076904-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076904-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076904-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076904-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076904-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076904-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076904-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076904-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076904-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076904-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076904-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076904-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076904-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0063-12024-05-13These 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 Initial U.S. Approval: 1993
17856-0063-22024-05-13These 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 Initial U.S. Approval: 1993
17856-0063-32024-05-13These 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 Initial U.S. Approval: 1993
17856-0063-42024-05-13These 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 Initial U.S. Approval: 1993
17856-0063-62024-05-13These 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 Initial U.S. Approval: 1993
17856-0063-72024-05-13These 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 Initial U.S. Approval: 1993
17856-0063-12023-01-30These 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 Initial U.S. Approval: 1993
17856-0063-22023-01-30These 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 Initial U.S. Approval: 1993
17856-0063-32023-01-30These 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 Initial U.S. Approval: 1993
17856-0063-42023-01-30These 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 Initial U.S. Approval: 1993
17856-0063-62023-01-30These 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 Initial U.S. Approval: 1993
17856-0063-72023-01-30These 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 Initial U.S. Approval: 1993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0063-41785600630448 SYRINGE in 1 BOX, UNIT-DOSE (17856-0063-4) > 4 mL in 1 SYRINGE48 syringe2020-05-290000-00-00NoNoCurrent