Risperidone

Product NDC
69238-2110
11-digit product format
692382110
Labeler code
69238
Product ID
69238-2110_a852094f-1084-4916-a185-e7ea35080780
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA078071
Marketing category
ANDA
Marketing start
2021-08-01
Substance
RISPERIDONE
Active strength
1 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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Risperidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE1 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312828Internal RxNorm lookup
312829Internal RxNorm lookup
312830Internal RxNorm lookup
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
e90c886c-132a-4df6-8604-cfe5ffa49d5bAvailable 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
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2110-5Risperidone500 in 1 BOTTLETABLET5006
69238-2110-6Risperidone60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2110RISPERIDONE TABLET [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 2 package rows20250223_e90c886c-132a-4df6-8604-cfe5ffa49d5b.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
ndc (product): 69238-2110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312829risperiDONE 0.5 MG Oral TabletPSNe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312830risperiDONE 1 MG Oral TabletPSNe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312831risperiDONE 2 MG Oral TabletPSNe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312832risperiDONE 3 MG Oral TabletPSNe90c886c-132a-4df6-8604-cfe5ffa49d5b6
314211risperiDONE 4 MG Oral TabletPSNe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312828risperidone 0.25 MG Oral TabletSCDe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312829risperidone 0.5 MG Oral TabletSCDe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312830risperidone 1 MG Oral TabletSCDe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312831risperidone 2 MG Oral TabletSCDe90c886c-132a-4df6-8604-cfe5ffa49d5b6
312832risperidone 3 MG Oral TabletSCDe90c886c-132a-4df6-8604-cfe5ffa49d5b6
314211risperidone 4 MG Oral TabletSCDe90c886c-132a-4df6-8604-cfe5ffa49d5b6
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
69238-2110-569238211005500 TABLET in 1 BOTTLE (69238-2110-5) 500 tablet2021-08-010000-00-00NoNoCurrent
69238-2110-66923821100660 TABLET in 1 BOTTLE (69238-2110-6) 60 tablet2021-08-010000-00-00NoNoCurrent