Risperidone

Product NDC
0615-8197
11-digit product format
006158197
Labeler code
0615
Product ID
0615-8197_102140c8-c00e-4498-8e1a-322d5de68198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077493
Marketing category
ANDA
Marketing start
2015-06-01
Substance
RISPERIDONE
Active strength
.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage0615-81970615-8197-30DDiscontinued by firm2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A077493-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2011-11-29
A077493-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2011-11-29
A077493-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2011-11-29
A077493-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2011-11-29
A077493-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2011-11-29
A077493-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2011-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077493-001AB
A077493-002AB
A077493-003AB
A077493-004AB
A077493-005AB
A077493-006AB

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 UTC2026-02A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-005RISPERIDONE3MGTABLET / ORALAB2011-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-006RISPERIDONE4MGTABLET / ORALAB2011-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-005RISPERIDONE3MGTABLET / ORALAB2011-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-006RISPERIDONE4MGTABLET / ORALAB2011-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-005RISPERIDONE3MGTABLET / ORALAB2011-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-006RISPERIDONE4MGTABLET / ORALAB2011-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-005RISPERIDONE3MGTABLET / ORALAB2011-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-006RISPERIDONE4MGTABLET / ORALAB2011-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-005RISPERIDONE3MGTABLET / ORALAB2011-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-006RISPERIDONE4MGTABLET / ORALAB2011-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-005RISPERIDONE3MGTABLET / ORALAB2011-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-006RISPERIDONE4MGTABLET / ORALAB2011-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-001RISPERIDONE0.25MGTABLET / ORALAB2011-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-002RISPERIDONE0.5MGTABLET / ORALAB2011-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-003RISPERIDONE1MGTABLET / ORALAB2011-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-004RISPERIDONE2MGTABLET / ORALAB2011-11-292680178bc6a6…

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 UTC2026-02A077493-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077493-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077493-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077493-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077493-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077493-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077493-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077493-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077493-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE.5 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 · 5 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7bbc37f1-6d6a-4021-8976-1f103ce1cfbdAvailable 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
0615-8197-05Risperidone15 in 1 BLISTER PACKTABLET1513
0615-8197-30Risperidone5 in 1 BLISTER PACKTABLET513
0615-8197-30Risperidone6 in 1 BOX, UNIT-DOSETABLET613
0615-8197-39Risperidone30 in 1 BLISTER PACKTABLET3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8197RISPERIDONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]13Current NDC, Legacy NDC, 4 package rows20230301_7bbc37f1-6d6a-4021-8976-1f103ce1cfbd.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONECoupler LLC55f3ebec-a742-48fc-e063-6394a90a14522026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONEREMEDYREPACK INC.c84807bd-35d7-4138-8989-42617d69293a2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONESolco Healthcare US, LLC43aa2a4f-1123-4f86-800b-9218882f7bcd2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONEREMEDYREPACK INC.3261e8cf-cc6e-4011-9246-aee623ad89712025-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONEREMEDYREPACK INC.339ec0af-c0f0-4115-8cdb-8f052e633f472025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONENuCare Pharmaceuticals, Inc.390904c2-fcfa-466e-e063-6394a90a03af2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONEBryant Ranch Prepack684dcda4-d270-400c-9798-7d920a038bbb2025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
RisperidoneRISPERIDONENCS HealthCare of KY, LLC dba Vangard Labs7bbc37f1-6d6a-4021-8976-1f103ce1cfbd2023-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493
ndc (product): 0615-8197
RisperidoneRISPERIDONEAphena Pharma Solutions - Tennessee, LLC58e422ec-da66-41b0-83c1-aefd940beda02019-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077493
application number: ANDA077493

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312829risperiDONE 0.5 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312830risperiDONE 1 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312831risperiDONE 2 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312832risperiDONE 3 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312828risperidone 0.25 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312829risperidone 0.5 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312830risperidone 1 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312831risperidone 2 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312832risperidone 3 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8197-050061581970515 TABLET in 1 BLISTER PACK (0615-8197-05) 15 tablet2018-02-280000-00-00NoNoCurrent
0615-8197-30006158197306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8197-30) > 5 TABLET in 1 BLISTER PACK6 blister pack2018-03-010000-00-00NoNoCurrent
0615-8197-390061581973930 TABLET in 1 BLISTER PACK (0615-8197-39) 30 tablet2018-02-280000-00-00NoNoCurrent