Home NDC 42291-909 Risperidone
Product NDC 42291-909
11-digit product format 422910909
Labeler code 42291
Product ID 42291-909_48ec0cc0-9916-db6b-e063-6294a90a4bea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA078071
Marketing category ANDA
Marketing start 2021-09-10
Substance RISPERIDONE
Active strength .5 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 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 A078071-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 A078071-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 A078071-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 A078071-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 A078071-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 A078071-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17
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 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078071-005 RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078071-006 RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078071-005 RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078071-006 RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078071-005 RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078071-006 RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078071-005 RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078071-006 RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078071-005 RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078071-006 RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078071-005 RISPERIDONE 3MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078071-006 RISPERIDONE 4MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078071-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2009-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078071-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2009-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078071-003 RISPERIDONE 1MG TABLET / ORAL AB 2009-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078071-004 RISPERIDONE 2MG TABLET / ORAL AB 2009-06-17 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-909-50 Risperidone 500 in 1 BOTTLE TABLET 500 4 42291-909-60 Risperidone 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-909 RISPERIDONE TABLET [AVKARE] 3 Current NDC, Legacy NDC, 1 package rows 20230111_cc97c0d4-4690-62be-e053-2a95a90a3a0c.zip 42291-909 RISPERIDONE TABLET [AVKARE] 2 Current NDC, Legacy NDC, 1 package rows 20230111_cba7628c-30b2-5d26-e053-2a95a90a3e57.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 Risperidone RISPERIDONE Amneal Pharmaceuticals NY LLC e90c886c-132a-4df6-8604-cfe5ffa49d5b 2025-02-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078071 application number: ANDA078071
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-909-50 42291090950 500 TABLET in 1 BOTTLE (42291-909-50) 500 tablet 2021-09-10 0000-00-00 No No Current 42291-909-60 42291090960 60 TABLET in 1 BOTTLE (42291-909-60) 60 tablet 2021-09-22 0000-00-00 No No Current