Home NDC 55289-463-30 RISPERDAL
Product NDC 55289-463
Requested package NDC 55289-463-30
11-digit product format 552890463
Labeler code 55289
Product ID 55289-463_e235c28a-74fd-9b76-e053-2995a90a6235
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 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 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 45 .
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 · 315 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 2026-11-14 07:37:17 2026-10 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 270 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 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 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-463-30 55289046330 30 TABLET in 1 BOTTLE, PLASTIC (55289-463-30) 30 tablet 2011-11-09 0000-00-00 No No Current