Risperidone

Product NDC
43353-412
Requested package NDC
43353-412-60
11-digit product format
433530412
Labeler code
43353
Product ID
43353-412_2ea2de52-7580-4e06-a06d-dd57572cc4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020272
Marketing category
NDA
Marketing start
1993-12-29
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
4 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage43353-41243353-412-60DDiscontinued by firm2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-41243353-412-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-41243353-412-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020272-001RISPERDALRISPERIDONE1MGTABLET / ORALABRLD, RS1993-12-29
N020272-002RISPERDALRISPERIDONE2MGTABLET / ORALABRLD1993-12-29
N020272-003RISPERDALRISPERIDONE3MGTABLET / ORALABRLD1993-12-29
N020272-004RISPERDALRISPERIDONE4MGTABLET / ORALABRLD1993-12-29
N020272-005RISPERDALRISPERIDONE5MGTABLET / ORAL1993-12-29
N020272-007RISPERDALRISPERIDONE0.5MGTABLET / ORALABRLD1999-01-27
N020272-008RISPERDALRISPERIDONE0.25MGTABLET / ORALABRLD1999-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020272-001AB
N020272-002AB
N020272-003AB
N020272-004AB
N020272-007AB
N020272-008AB

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 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-005RISPERDAL5MGTABLET / ORAL1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2903ed91905a0d…

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 UTC2026-02N020272-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020272-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-007AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020272-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020272-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020272-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020272-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020272-004AB12680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-412-15EA - Each43353-41263845d43-ee4a-4890-9c8e-b99273c927ca12018-06-11
43353-412-30EA - Each43353-412623b37e3-52f5-46e5-adab-74e1ad9da42512018-06-11
43353-412-45EA - Each43353-412ec4bc93d-3f40-4af8-8dfb-cc57e3907dc212018-06-11
43353-412-60EA - Each43353-412f8d4c9a5-d497-4e4f-a8ca-040a07c8d28a12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-412RISPERIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180516_1d0bba84-252f-4aff-950b-fb7c7e787cda.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RISPERDALRISPERIDONEJanssen Pharmaceuticals, Inc.7e117c7e-02fc-4343-92a1-230061dfc5e02026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020272
application number: NDA020272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-412-604335304126090 TABLET in 1 BOTTLE (43353-412-60) 90 tablet2018-02-260000-00-00NoNoCurrent