Risperidone

Product NDC
21695-087
11-digit product format
216950087
Labeler code
21695
Product ID
21695-087_2e8fb017-8754-421a-a76a-c41b8f48070b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA079088
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-087IInactivated by FDA2026-08-03
excluded packagepackage21695-08721695-087-60IInactivated by FDA2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-087-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-087-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-087-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-087-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-087-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-087-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-087-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-087-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-087-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-087-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-087-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-087-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-087-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-087-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-087-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-087-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-087-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-087-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-087-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-087-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-087-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-087-60110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079088-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-10-30
A079088-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-10-30
A079088-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-10-30
A079088-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-10-30
A079088-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-10-30
A079088-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A079088-001AB
A079088-002AB
A079088-003AB
A079088-004AB
A079088-005AB
A079088-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-004AB12680178bc6a6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6Product name520250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09eProduct name120250128
e457a910-2c3a-4bfd-90b9-0310982c50ddProduct name120241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-087-60Risperidone60 in 1 BLISTER PACKTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-087-60EA - Each21695-08776b23c79-7030-49ce-85f5-d96e71d0bb0812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-087RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111220_2e8fb017-8754-421a-a76a-c41b8f48070b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEPD-Rx Pharmaceuticals, Inc.e72a2768-815f-47bf-b2f9-16a93dd106842026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079088
application number: ANDA079088
RisperidoneRISPERIDONETorrent Pharmaceuticals Limiteda6347895-5f16-43b4-92a0-b9904ac819372026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079088
application number: ANDA079088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312829risperiDONE 0.5 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312830risperiDONE 1 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312831risperiDONE 2 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312832risperiDONE 3 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312828risperidone 0.25 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312829risperidone 0.5 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312830risperidone 1 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312831risperidone 2 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312832risperidone 3 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-087-602169500876060 in 1 BLISTER PACKHistorical