Home NDC 72789-461 RISPERIDONE
Product NDC 72789-461
11-digit product format 727890461
Labeler code 72789
Product ID 72789-461_4db273b0-d906-4596-e063-6394a90a57db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RISPERIDONE
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA201003
Marketing category ANDA
Marketing start 2014-03-28
Substance RISPERIDONE
Active strength 2 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A201003-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 A201003-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 A201003-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 A201003-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 A201003-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 A201003-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24
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 · 258 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 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201003-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201003-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201003-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201003-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201003-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201003-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201003-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201003-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201003-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201003-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201003-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201003-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201003-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201003-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201003-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201003-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-08-24 b8a1b40f171c…
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.
Additional Listing Data#
Finished product Yes
Brand name base RISPERIDONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISPERIDONE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L6UH7ZF8HC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312831 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72789-461-14 RISPERIDONE 14 in 1 BOTTLE, PLASTIC TABLET 14 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-461 RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.] 18 Current NDC, 1 package rows 20250503_bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5.zip
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 2 of 2 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RISPERIDONE RISPERIDONE Proficient Rx LP 2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2 2022-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201003 application number: ANDA201003 RISPERIDONE RISPERIDONE Proficient Rx LP 088dc3dd-7740-471b-8c06-5a47900ae5b5 2022-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201003 application number: ANDA201003 RISPERIDONE RISPERIDONE Proficient Rx LP 1b5c9889-4dc3-48df-8629-4ac099e2b4c0 2022-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201003 application number: ANDA201003 RISPERIDONE RISPERIDONE Proficient Rx LP 394c7e27-52a2-4d4c-8c6e-fe37b03266ae 2022-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201003 application number: ANDA201003 RISPERIDONE RISPERIDONE Aphena Pharma Solutions - Tennessee, LLC ac152803-d75f-4c3c-bc49-8663b21a3a82 2019-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201003 application number: ANDA201003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-461-14 72789046114 14 TABLET in 1 BOTTLE, PLASTIC (72789-461-14) 14 tablet 2024-12-23 No No Current