Risperidone

Product NDC
0904-6358
Requested package NDC
0904-6358-61
11-digit product format
009046358
Labeler code
0904
Product ID
0904-6358_f68fdc24-2093-4ac8-9a03-5f03f5bf0b8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA079088
Marketing category
ANDA
Marketing start
2013-11-30
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage0904-63580904-6358-61DDiscontinued 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 · 6 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…

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
A079088-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-10-30
A079088-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-10-30
A079088-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-10-30
A079088-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-10-30
A079088-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-10-30
A079088-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079088-001AB
A079088-002AB
A079088-003AB
A079088-004AB
A079088-005AB
A079088-006AB

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 UTC2026-02A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-302680178bc6a6…

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 UTC2026-02A079088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-004AB12680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6358-61EA - Each0904-6358cf9b2306-d5ae-49b2-9995-fadbeb3db24a12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [CARDINAL HEALTH]6
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [CARDINAL HEALTH]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [CARDINAL HEALTH]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [CARDINAL HEALTH]6
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KRISPERIDONE TABLET [CARDINAL HEALTH]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRISPERIDONE TABLET [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [CARDINAL HEALTH]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRISPERIDONE TABLET [CARDINAL HEALTH]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [CARDINAL HEALTH]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [CARDINAL HEALTH]6
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TRISPERIDONE TABLET [CARDINAL HEALTH]6
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [CARDINAL HEALTH]6
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [MAJOR PHARMACEUTICALS]1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEPD-Rx Pharmaceuticals, Inc.e72a2768-815f-47bf-b2f9-16a93dd106842026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079088
application number: ANDA079088
RisperidoneRISPERIDONETorrent Pharmaceuticals Limiteda6347895-5f16-43b4-92a0-b9904ac819372026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079088
application number: ANDA079088

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6358-6100904635861100 TABLET in 1 BOX, UNIT-DOSE (0904-6358-61) 100 tablet2013-11-300000-00-00NoNoCurrent