Home NDC 53808-0876 Risperidone
Product NDC 53808-0876
11-digit product format 538080876
Labeler code 53808
Product ID 53808-0876_76437cab-3ca6-4e54-9c58-803f50404969
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA076288
Marketing category ANDA
Marketing start 2013-01-01
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 1 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 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 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0876-2 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0876-2 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0876-2 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0876-2 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0876-2 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0876-2 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0876-2 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0876-2 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0876-2 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0876-2 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0876-2 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0876-2 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0876-2 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0876-2 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0876-2 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0876-2 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0876-2 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0876-2 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0876-2 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0876-2 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0876-2 9bebd1f3094a…5416666fcb17…
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 A076288-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 A076288-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 A076288-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL 2008-09-15 A076288-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL 2008-09-15 A076288-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL 2008-09-15 A076288-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL 2008-09-15
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 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 2680178bc6a6…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-0876-2 Risperidone 60 in 1 BLISTER PACK TABLET, FILM COATED 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0876 RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20140415_5db40498-428b-43d2-b29d-d351bf709585.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0876-2 53808087602 60 in 1 BLISTER PACK Historical