Risperidone

Product NDC
42291-909
Requested package NDC
42291-909-60
11-digit product format
422910909
Labeler code
42291
Product ID
42291-909_48ec0cc0-9916-db6b-e063-6294a90a4bea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA078071
Marketing category
ANDA
Marketing start
2021-09-10
Substance
RISPERIDONE
Active strength
.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage42291-90942291-909-60DDiscontinued 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
A078071-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2009-06-17
A078071-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2009-06-17
A078071-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2009-06-17
A078071-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2009-06-17
A078071-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2009-06-17
A078071-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2009-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078071-001AB
A078071-002AB
A078071-003AB
A078071-004AB
A078071-005AB
A078071-006AB

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 UTC2026-02A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-005RISPERIDONE3MGTABLET / ORALAB2009-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-006RISPERIDONE4MGTABLET / ORALAB2009-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-005RISPERIDONE3MGTABLET / ORALAB2009-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-006RISPERIDONE4MGTABLET / ORALAB2009-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-005RISPERIDONE3MGTABLET / ORALAB2009-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-006RISPERIDONE4MGTABLET / ORALAB2009-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-005RISPERIDONE3MGTABLET / ORALAB2009-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-006RISPERIDONE4MGTABLET / ORALAB2009-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-005RISPERIDONE3MGTABLET / ORALAB2009-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-006RISPERIDONE4MGTABLET / ORALAB2009-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-005RISPERIDONE3MGTABLET / ORALAB2009-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-006RISPERIDONE4MGTABLET / ORALAB2009-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-001RISPERIDONE0.25MGTABLET / ORALAB2009-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-002RISPERIDONE0.5MGTABLET / ORALAB2009-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-003RISPERIDONE1MGTABLET / ORALAB2009-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-004RISPERIDONE2MGTABLET / ORALAB2009-06-172680178bc6a6…

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 UTC2026-02A078071-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078071-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078071-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078071-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078071-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078071-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078071-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078071-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078071-004AB12680178bc6a6…

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
42291-909-50Risperidone500 in 1 BOTTLETABLET5004
42291-909-60Risperidone60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-909-50EA - Each42291-9092b0ad3f9-1d8d-4e70-a4e0-1309d9c0125d12021-11-09
42291-909-60EA - Each42291-909a15be477-283a-493e-aa4c-506514fd3d5b12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-909RISPERIDONE TABLET [AVKARE]3Current NDC, Legacy NDC, 1 package rows20230111_cc97c0d4-4690-62be-e053-2a95a90a3a0c.zip
42291-909RISPERIDONE TABLET [AVKARE]2Current NDC, Legacy NDC, 1 package rows20230111_cba7628c-30b2-5d26-e053-2a95a90a3e57.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
RisperidoneRISPERIDONEAmneal Pharmaceuticals NY LLCe90c886c-132a-4df6-8604-cfe5ffa49d5b2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078071
application number: ANDA078071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312829risperiDONE 0.5 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312830risperiDONE 1 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312831risperiDONE 2 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312832risperiDONE 3 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
314211risperiDONE 4 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312828risperidone 0.25 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312829risperidone 0.5 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312830risperidone 1 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312831risperidone 2 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312832risperidone 3 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
314211risperidone 4 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312828risperiDONE 0.25 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312829risperiDONE 0.5 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312830risperiDONE 1 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312831risperiDONE 2 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312832risperiDONE 3 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
314211risperiDONE 4 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312828risperidone 0.25 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312829risperidone 0.5 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312830risperidone 1 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312831risperidone 2 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312832risperidone 3 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
314211risperidone 4 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-909-604229109096060 TABLET in 1 BOTTLE (42291-909-60) 60 tablet2021-09-220000-00-00NoNoCurrent