Risperidone

Product NDC
42291-978
11-digit product format
422910978
Labeler code
42291
Product ID
42291-978_3d4c5818-d71d-e4d0-e063-6394a90a9679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA078707
Marketing category
ANDA
Marketing start
2025-08-27
Substance
RISPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A078707-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-12-29
A078707-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-12-29
A078707-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-12-29
A078707-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-12-29
A078707-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-12-29
A078707-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078707-001AB
A078707-002AB
A078707-003AB
A078707-004AB
A078707-005AB
A078707-006AB

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 UTC2026-02A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-005RISPERIDONE3MGTABLET / ORALAB2008-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-006RISPERIDONE4MGTABLET / ORALAB2008-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-005RISPERIDONE3MGTABLET / ORALAB2008-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-006RISPERIDONE4MGTABLET / ORALAB2008-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-005RISPERIDONE3MGTABLET / ORALAB2008-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-006RISPERIDONE4MGTABLET / ORALAB2008-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-005RISPERIDONE3MGTABLET / ORALAB2008-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-006RISPERIDONE4MGTABLET / ORALAB2008-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-005RISPERIDONE3MGTABLET / ORALAB2008-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-006RISPERIDONE4MGTABLET / ORALAB2008-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-005RISPERIDONE3MGTABLET / ORALAB2008-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-006RISPERIDONE4MGTABLET / ORALAB2008-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-001RISPERIDONE0.25MGTABLET / ORALAB2008-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-002RISPERIDONE0.5MGTABLET / ORALAB2008-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-003RISPERIDONE1MGTABLET / ORALAB2008-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-004RISPERIDONE2MGTABLET / ORALAB2008-12-292680178bc6a6…

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 UTC2026-02A078707-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078707-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078707-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078707-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078707-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078707-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078707-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078707-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078707-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Risperidone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L6UH7ZF8HCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312831Internal RxNorm lookup
312832Internal RxNorm lookup
314211Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d4c51e2-b09b-9fd0-e063-6294a90ae699Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-978-50Risperidone500 in 1 BOTTLETABLET, FILM COATED5001
42291-978-60Risperidone60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-978-50EA - Each42291-978c2db57e4-f2ce-40db-a09b-d08018387a0712025-10-14
42291-978-60EA - Each42291-9788c8be576-19df-445d-80d2-e621ac03c0f812025-10-14

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEWestminster Pharmaceuticals, LLC07d43bf6-a695-453a-a5c7-9581effe585c2025-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078707
application number: ANDA078707
RisperidoneRISPERIDONEAvKARE3d4c51e2-b09b-9fd0-e063-6294a90ae6992025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078707
application number: ANDA078707
ndc (product): 42291-978
RisperidoneRISPERIDONEAvKARE2f9ea0cc-b86b-a11f-e063-6294a90a96202025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078707
application number: ANDA078707

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312831risperiDONE 2 MG Oral TabletPSN3d4c51e2-b09b-9fd0-e063-6294a90ae6991
312832risperiDONE 3 MG Oral TabletPSN3d4c51e2-b09b-9fd0-e063-6294a90ae6991
314211risperiDONE 4 MG Oral TabletPSN3d4c51e2-b09b-9fd0-e063-6294a90ae6991
312831risperidone 2 MG Oral TabletSCD3d4c51e2-b09b-9fd0-e063-6294a90ae6991
312832risperidone 3 MG Oral TabletSCD3d4c51e2-b09b-9fd0-e063-6294a90ae6991
314211risperidone 4 MG Oral TabletSCD3d4c51e2-b09b-9fd0-e063-6294a90ae6991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-978-5042291097850500 TABLET, FILM COATED in 1 BOTTLE (42291-978-50) 2025-08-27NoNoCurrent
42291-978-604229109786060 TABLET, FILM COATED in 1 BOTTLE (42291-978-60) 2025-08-27NoNoCurrent