RISPERIDONE

Product NDC
71610-246
Requested package NDC
71610-246-15
11-digit product format
716100246
Labeler code
71610
Product ID
71610-246_1ed35e98-e193-4975-917c-86bb64acf404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-03-28
Substance
RISPERIDONE
Active strength
4 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
A201003-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2011-08-24
A201003-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2011-08-24
A201003-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2011-08-24
A201003-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2011-08-24
A201003-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2011-08-24
A201003-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2011-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201003-001AB
A201003-002AB
A201003-003AB
A201003-004AB
A201003-005AB
A201003-006AB

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 UTC2026-02A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-242680178bc6a6…

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 UTC2026-02A201003-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201003-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE4 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
bda104ac-1eea-4a1a-836a-24bcc034b90fAvailable 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
71610-246-15RISPERIDONE15 in 1 BOTTLETABLET153
71610-246-30RISPERIDONE30 in 1 BOTTLETABLET303
71610-246-45RISPERIDONE45 in 1 BOTTLETABLET453
71610-246-53RISPERIDONE60 in 1 BOTTLETABLET603
71610-246-60RISPERIDONE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-246-15EA - Each71610-2467e7b1f66-82ff-4b30-8c22-38e3458dc30812019-05-02
71610-246-30EA - Each71610-24614e2436c-454c-4f14-aa03-19f071f3d92012019-05-02
71610-246-45EA - Each71610-24690a86b80-7986-43ce-83ec-d11ad4deed0112019-05-02
71610-246-53EA - Each71610-246fd7e01fb-f2c9-4c45-a971-508038e07df012022-12-07
71610-246-60EA - Each71610-246c7d195b7-f7a0-49c4-b7a2-b03275edee6612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-246RISPERIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20221110_bda104ac-1eea-4a1a-836a-24bcc034b90f.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RISPERIDONERISPERIDONECoupler LLC5643c32b-310e-4888-e063-6394a90ab62f2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee495f20-c668-4d8f-9684-1029a4f232db2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.03d3b52d-3a7d-4595-84c9-332da6ca91712026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONECoupler LLC52bb35ac-1f7d-bfbe-e063-6294a90aa2b92026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEA-S Medication Solutionsa6767972-2d3f-482b-80bd-ac93e28fdd052026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.bdb08381-dbfc-442e-8d3c-22d3a0f2f6c52026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.2776a647-678d-465c-9db3-4a9459ce779e2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.5d9519af-5a5e-47ce-8a0f-9b9cfac00e192026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee7d6779-7421-4761-99d2-ccbfde9385a82026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.101b2d4d-4740-4225-94bc-aecc05d82c6b2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEAjanta Pharma USA Inc.095630bd-a77e-434e-94ee-f13da445d8f22025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.be388943-fe0c-4c82-ac8e-3df9f77b28912025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RisperidoneRISPERIDONEDirect_Rx0b784f21-fc02-6542-e063-6294a90a285e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONENuCare Pharmaceuticals,Inc.79648a52-1364-c25b-e053-2a91aa0a8ea42024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepack420cfeef-0061-43b9-9491-dbd6ad866e552024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepackaab773b2-a605-4cf8-a301-57e390fe67a62024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepack2f83d3e9-04ab-4b24-ad1f-7ed2e784298a2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepacke35be034-6275-41fb-bec4-9ae4514587012024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEA-S Medication Solutions523d4f99-1d6f-413f-9d6e-2ca430aaac142024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEAphena Pharma Solutions - Tennessee, LLCbda104ac-1eea-4a1a-836a-24bcc034b90f2022-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
ndc (package): 71610-246-15
ndc (product): 71610-246
ndc11 (package): 71610024615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314211risperiDONE 4 MG Oral TabletPSNbda104ac-1eea-4a1a-836a-24bcc034b90f3
314211risperidone 4 MG Oral TabletSCDbda104ac-1eea-4a1a-836a-24bcc034b90f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-246-157161002461515 TABLET in 1 BOTTLE (71610-246-15) 15 tablet2019-03-040000-00-00NoNoCurrent