RISPERIDONE

Product NDC
50090-3344
11-digit product format
500903344
Labeler code
50090
Product ID
50090-3344_1346af4e-0b3d-468c-8c06-3dd0224ca180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-03-28
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3344DDiscontinued by firm2026-08-03
excluded packagepackage50090-334450090-3344-0DDiscontinued by firm2026-08-03

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
A201003-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2011-08-24
A201003-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2011-08-24
A201003-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2011-08-24
A201003-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2011-08-24
A201003-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2011-08-24
A201003-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2011-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201003-001AB
A201003-002AB
A201003-003AB
A201003-004AB
A201003-005AB
A201003-006AB

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 UTC2026-02A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-242680178bc6a6…

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 UTC2026-02A201003-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201003-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-004AB12680178bc6a6…

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
50090-3344-0RISPERIDONE30 in 1 BOTTLETABLET3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3344-0EA - Each50090-3344fb3a0ab3-6fe3-4e19-b182-fa490f3c1ab112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3344RISPERIDONE TABLET [A-S MEDICATION SOLUTIONS]20Legacy NDC, 1 package rows20230208_a6767972-2d3f-482b-80bd-ac93e28fdd05.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RISPERIDONERISPERIDONECoupler LLC5643c32b-310e-4888-e063-6394a90ab62f2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee495f20-c668-4d8f-9684-1029a4f232db2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.03d3b52d-3a7d-4595-84c9-332da6ca91712026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONECoupler LLC52bb35ac-1f7d-bfbe-e063-6294a90aa2b92026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEA-S Medication Solutionsa6767972-2d3f-482b-80bd-ac93e28fdd052026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
ndc (product): 50090-3344
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.bdb08381-dbfc-442e-8d3c-22d3a0f2f6c52026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.2776a647-678d-465c-9db3-4a9459ce779e2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.5d9519af-5a5e-47ce-8a0f-9b9cfac00e192026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee7d6779-7421-4761-99d2-ccbfde9385a82026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.101b2d4d-4740-4225-94bc-aecc05d82c6b2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEAjanta Pharma USA Inc.095630bd-a77e-434e-94ee-f13da445d8f22025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.be388943-fe0c-4c82-ac8e-3df9f77b28912025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RisperidoneRISPERIDONEDirect_Rx0b784f21-fc02-6542-e063-6294a90a285e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONENuCare Pharmaceuticals,Inc.79648a52-1364-c25b-e053-2a91aa0a8ea42024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepack420cfeef-0061-43b9-9491-dbd6ad866e552024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepackaab773b2-a605-4cf8-a301-57e390fe67a62024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepack2f83d3e9-04ab-4b24-ad1f-7ed2e784298a2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepacke35be034-6275-41fb-bec4-9ae4514587012024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEA-S Medication Solutions523d4f99-1d6f-413f-9d6e-2ca430aaac142024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEAphena Pharma Solutions - Tennessee, LLCbda104ac-1eea-4a1a-836a-24bcc034b90f2022-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312829risperiDONE 0.5 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312830risperiDONE 1 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312831risperiDONE 2 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312828risperidone 0.25 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312829risperidone 0.5 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312830risperidone 1 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312831risperidone 2 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3344-05009033440030 TABLET in 1 BOTTLE (50090-3344-0) 30 tablet2018-01-220000-00-00NoNoCurrent