Home NDC 55289-465 RISPERDAL
Product NDC 55289-465
11-digit product format 552890465
Labeler code 55289
Product ID 55289-465_e23554ab-2250-e8a8-e053-2995a90a6abf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020272
Marketing category NDA
Marketing start 1993-12-29
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 2 mg/1
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 · 24 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 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 55289-465-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020272-001 RISPERDAL RISPERIDONE 1MG TABLET / ORAL AB RLD, RS 1993-12-29 N020272-002 RISPERDAL RISPERIDONE 2MG TABLET / ORAL AB RLD 1993-12-29 N020272-003 RISPERDAL RISPERIDONE 3MG TABLET / ORAL AB RLD 1993-12-29 N020272-004 RISPERDAL RISPERIDONE 4MG TABLET / ORAL AB RLD 1993-12-29 N020272-005 RISPERDAL RISPERIDONE 5MG TABLET / ORAL 1993-12-29 N020272-007 RISPERDAL RISPERIDONE 0.5MG TABLET / ORAL AB RLD 1999-01-27 N020272-008 RISPERDAL RISPERIDONE 0.25MG TABLET / ORAL AB RLD 1999-05-10
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 8 · 301 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 2026-09-14 22:38:34 2026-08 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded risperidone ACTIVE INGREDIENT L6UH7ZF8HC RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 risperidone ACTIVE MOIETY L6UH7ZF8HC RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 starch, corn INACTIVE INGREDIENT O8232NY3SJ RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 talc INACTIVE INGREDIENT 7SEV7J4R1U RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12
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 RISPERDAL RISPERIDONE Janssen Pharmaceuticals, Inc. 7e117c7e-02fc-4343-92a1-230061dfc5e0 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020272 application number: NDA020272
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-465-30 55289046530 30 TABLET in 1 BOTTLE, PLASTIC (55289-465-30) 30 tablet 2011-09-01 0000-00-00 No No Current