Risperidone

Product NDC
63629-2284
Requested package NDC
63629-2284-1
11-digit product format
636292284
Labeler code
63629
Product ID
63629-2284_1b881f15-3792-4226-8184-8c5bf598cdd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077494
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
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 packagepackage63629-228463629-2284-1DDiscontinued by firm2026-08-07

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 · 11 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…

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
A077494-001RISPERIDONERISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-30
A077494-002RISPERIDONERISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30
A077494-003RISPERIDONERISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-26
A077494-004RISPERIDONERISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30
A077494-005RISPERIDONERISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30
A077494-006RISPERIDONERISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077494-002AB
A077494-003AB
A077494-004AB
A077494-005AB
A077494-006AB

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 UTC2026-02A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-005RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-006RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-005RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-006RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-005RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-006RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-005RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-006RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-005RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-006RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-005RISPERIDONE3MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-006RISPERIDONE4MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-001RISPERIDONE0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2009-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-002RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-003RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-004RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-04-302680178bc6a6…

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 UTC2026-02A077494-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077494-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077494-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077494-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077494-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077494-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077494-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077494-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077494-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077494-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077494-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077494-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077494-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077494-006AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2284-1EA - Each63629-2284dae856c5-0dc1-469a-9231-fbf93be79b7712021-07-15

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEPar Health USA, LLCd0ef6df3-67e5-47b1-bcf7-f67aa030caca2024-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077494
application number: ANDA077494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2284-1636292284017 BLISTER PACK in 1 CARTON (63629-2284-1) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK7 blister pack2021-03-290000-00-00NoNoCurrent