Home NDC 0904-6360-61 Risperidone
Product NDC 0904-6360
Requested package NDC 0904-6360-61
11-digit product format 009046360
Labeler code 0904
Product ID 0904-6360_f68fdc24-2093-4ac8-9a03-5f03f5bf0b8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA079088
Marketing category ANDA
Marketing start 2013-11-30
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 · 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 0904-6360 0904-6360-61 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-6360 0904-6360-61 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079088-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 A079088-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 A079088-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 A079088-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 A079088-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 A079088-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30
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 · 246 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 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Socrata Ingredients# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6360-61 00904636061 100 TABLET in 1 BOX, UNIT-DOSE (0904-6360-61) 100 tablet 2013-11-30 0000-00-00 No No Current