Risperidone

Product NDC
0781-5313
11-digit product format
007815313
Labeler code
0781
Product ID
0781-5313_483b5267-344e-4ba9-b6d8-a8bff8f7108e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA078116
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
3 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5313DDiscontinued by firm2026-08-03
excluded packagepackage0781-53130781-5313-08DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5313-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5313-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5313-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5313-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5313-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5313-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5313-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5313-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5313-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5313-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5313-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5313-08557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078116-001RISPERIDONERISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22
A078116-002RISPERIDONERISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22
A078116-003RISPERIDONERISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22
A078116-004RISPERIDONERISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22
A078116-005RISPERIDONERISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A078116-001AB
A078116-002AB
A078116-003AB
A078116-004AB
A078116-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-004RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-005RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-12-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078116-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078116-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078116-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078116-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078116-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078116-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078116-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078116-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078116-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078116-005AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5313-06EA - Each0781-53132af3023a-956b-42aa-93ce-3f8aa246d5ed12016-12-07
0781-5313-08EA - Each0781-53139dc37606-a7cc-4b25-b820-86cbd866cd2012012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5313-080078153130828 BLISTER PACK in 1 CARTON (0781-5313-08) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5313-06) 28 blister pack2009-12-220000-00-00NoNoCurrent