Home NDC 50090-3006-0 Risperidone
Product NDC 50090-3006
Requested package NDC 50090-3006-0
11-digit product format 500903006
Labeler code 50090
Product ID 50090-3006_07a8a2b0-83e1-47e1-a8f4-4caed3e6b2f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler A-S Medication Solutions
Application ANDA090839
Marketing category ANDA
Marketing start 2011-11-04
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 · 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 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090839-001 RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 A090839-002 RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 A090839-003 RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 A090839-004 RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 A090839-005 RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 220 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 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Risperidone RISPERIDONE Jubilant Cadista Pharmacuticals Inc. 739dcf8a-ed73-5eb0-899b-7e51cb73c335 2025-10-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090839 application number: ANDA090839
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-3006-0 50090300600 7 BLISTER PACK in 1 CARTON (50090-3006-0) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 7 blister pack 2017-05-08 0000-00-00 No No Current