Home NDC 43353-412-30 Risperidone
Product NDC 43353-412
Requested package NDC 43353-412-30
11-digit product format 433530412
Labeler code 43353
Product ID 43353-412_2ea2de52-7580-4e06-a06d-dd57572cc4aa
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 4 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-412 43353-412-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-412 43353-412-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 287 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 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-412 RISPERIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20180516_1d0bba84-252f-4aff-950b-fb7c7e787cda.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 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 43353-412-30 43353041230 30 TABLET in 1 BOTTLE (43353-412-30) 30 tablet 2018-01-29 0000-00-00 No No Current