RISPERIDONE

Product NDC
61919-572
Requested package NDC
61919-572-60
11-digit product format
619190572
Labeler code
61919
Product ID
61919-572_9cad1861-e8f9-0ee6-e053-2995a90aba73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078040
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage61919-57261919-572-60IInactivated by FDA2026-08-03

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A078040-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-10-16
A078040-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-10-16
A078040-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-10-16
A078040-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-10-16
A078040-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-10-16
A078040-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078040-001AB
A078040-002AB
A078040-003AB
A078040-004AB
A078040-005AB
A078040-006AB

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 UTC2026-02A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-162680178bc6a6…

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 UTC2026-02A078040-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078040-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-004AB12680178bc6a6…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-572-602023-01-30C16284748780-1f386c649-a11b-0266-e053-dadaa90a7c1aRISPERIDONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-572-60RISPERIDONE60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-572-60EA - Each61919-572f0113fd1-675a-4293-b4e5-4d4c25ecb00e12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-572RISPERIDONE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20200130_89595dbd-2722-41f2-88ae-8c43769702bf.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
risperidoneRISPERIDONECardinal Health 107, LLC3ce21196-4aa0-469b-8f04-6650b2c48cb52026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEMajor Pharmaceuticalsd5abd75f-7f4a-4a7d-b849-82fce88f5ff72026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
RisperidoneRISPERIDONEAmerican Health Packagingf11dae15-b057-4258-9229-3819d0c980fe2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEZydus Pharmaceuticals USA Inc.713b5ac7-53d6-4139-8599-3028f789de4b2025-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEZydus Lifesciences Limited23993d21-80bf-41c4-b57d-88a620173b6b2024-08-12Exact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEProficient Rx LPb611fe52-1787-47e6-8a6b-1999a4e4f22c2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSN89595dbd-2722-41f2-88ae-8c43769702bf3
312830risperidone 1 MG Oral TabletSCD89595dbd-2722-41f2-88ae-8c43769702bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-572-606191905726060 TABLET, FILM COATED in 1 BOTTLE (61919-572-60) 2014-01-010000-00-00NoNoCurrent