Home NDC 43353-720 Risperidone
Product NDC 43353-720
11-digit product format 433530720
Labeler code 43353
Product ID 43353-720_42231505-eb36-4128-829b-2a66dc8ad832
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
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 2020-12-31
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 · 8 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 43353-720-45 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-720-15 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-720-30 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 43353-720-45 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-720-15 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-720-30 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 308 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 2026-10-15 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…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-720 RISPERIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20180516_9937dce3-c339-4f80-85c6-14277ce0c4b5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-720-15 43353072015 15 TABLET in 1 BOTTLE (43353-720-15) 15 tablet 2018-03-27 0000-00-00 No No Current 43353-720-30 43353072030 30 TABLET in 1 BOTTLE (43353-720-30) 30 tablet 2018-04-10 0000-00-00 No No Current 43353-720-45 43353072045 45 TABLET in 1 BOTTLE (43353-720-45) 45 tablet 2018-04-10 0000-00-00 No No Current