Risperidone

Product NDC
43353-412
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-412DDiscontinued by firm2026-10-30
excluded packagepackage43353-41243353-412-15DDiscontinued by firm2026-10-30
excluded packagepackage43353-41243353-412-30DDiscontinued by firm2026-10-30
excluded packagepackage43353-41243353-412-45DDiscontinued by firm2026-10-30
excluded packagepackage43353-41243353-412-60DDiscontinued by firm2026-10-30

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 · 10 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 packagepackage43353-412-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-412-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-412-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-412-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-412-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-412-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-412-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-412-60f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 308 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27c2088c7a36db…
2026-10-15 13:18:302026-09N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10c2088c7a36db…
2026-09-14 22:38:342026-08N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-1084e616aacf4f…
2026-08-18 06:07:402026-07N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020272-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-007AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-008AB1c2088c7a36db…
2026-09-14 22:38:342026-08N020272-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-007AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-008AB184e616aacf4f…
2026-08-18 06:07:402026-07N020272-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-008AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-412-154335304121515 TABLET in 1 BOTTLE (43353-412-15) 15 tablet2018-01-290000-00-00NoNoCurrent
43353-412-304335304123030 TABLET in 1 BOTTLE (43353-412-30) 30 tablet2018-01-290000-00-00NoNoCurrent
43353-412-454335304124545 TABLET in 1 BOTTLE (43353-412-45) 45 tablet2018-03-010000-00-00NoNoCurrent
43353-412-604335304126090 TABLET in 1 BOTTLE (43353-412-60) 90 tablet2018-02-260000-00-00NoNoCurrent