Home NDC 54838-563-30 Risperidone
Product NDC 54838-563
Requested package NDC 54838-563-30
11-digit product format 548380563
Labeler code 54838
Product ID 54838-563_a34c4769-eafb-4130-94e4-5490b336994b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA202386
Marketing category ANDA
Marketing start 2015-01-30
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 1 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202386-001 RISPERIDONE RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202386-001 AA
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 2 · 41 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 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2015-01-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202386-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2015-01-12 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RISPERIDONE RISPERIDONE Chartwell RX, LLC 66390528-7517-452a-ae76-4338ec7db3ae 2023-10-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202386 application number: ANDA202386
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-563-30 54838056330 30 mL in 1 BOTTLE (54838-563-30) 30 ml 2015-01-30 0000-00-00 No No Current