Home NDC 64679-553 Risperidone
Product NDC 64679-553
11-digit product format 646790553
Labeler code 64679
Product ID 64679-553_b3eefb63-0cd7-4733-b75a-1088cc99e115
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA078871
Marketing category ANDA
Marketing start 2008-10-09
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 0 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-553-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-553-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-553-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-553-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-553-03 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-553-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-553-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-553-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-553-03 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-553-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-553-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-553-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-553-03 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-553-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-553-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-553-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-553-03 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-553-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-553-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-553-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-553-03 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-553-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-553-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-553-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-553-03 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-553-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-553-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-553-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-553-03 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-553-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-553-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-553-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-553-03 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-553-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-553-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-553-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-553-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-553-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-553-03 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-553-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-553-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-553-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-553-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-553-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-553-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-553-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-553-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-553-02 I Inactivated by FDA 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078871-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 A078871-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 A078871-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 A078871-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 A078871-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 A078871-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-553-01 2024-11-15 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-02 2024-11-15 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-03 2024-11-15 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-04 2024-11-15 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-01 2020-01-31 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-02 2020-01-31 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-03 2020-01-31 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993 64679-553-04 2020-01-31 These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET, FILM COATED [WOCKHARDT USA LLC] 2