Home NDC 43353-755 Risperidone
Product NDC 43353-755
11-digit product format 433530755
Labeler code 43353
Product ID 43353-755_9139290e-82d1-40ea-afbe-4fd7be934799
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA076288
Marketing category ANDA
Marketing start 2008-09-17
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 1 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A076288-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 A076288-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 A076288-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL 2008-09-15 A076288-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL 2008-09-15 A076288-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL 2008-09-15 A076288-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL 2008-09-15
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 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-005 RISPERIDONE 3MG TABLET / ORAL 2008-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076288-006 RISPERIDONE 4MG TABLET / ORAL 2008-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-001 RISPERIDONE 0.25MG TABLET / ORAL 2008-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-002 RISPERIDONE 0.5MG TABLET / ORAL 2008-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-003 RISPERIDONE 1MG TABLET / ORAL 2008-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076288-004 RISPERIDONE 2MG TABLET / ORAL 2008-09-15 2680178bc6a6…
Observed Orange Book normalized TE history# 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 43353-755-15 Risperidone 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 3 43353-755-30 Risperidone 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 3 43353-755-45 Risperidone 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 3 43353-755-60 Risperidone 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-755 RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC, 4 package rows 20140509_50aec836-fbfd-49af-9448-912b8279a7f9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-755-15 43353075515 15 in 1 BOTTLE, PLASTIC Historical 43353-755-30 43353075530 30 in 1 BOTTLE, PLASTIC Historical 43353-755-45 43353075545 45 in 1 BOTTLE, PLASTIC Historical 43353-755-60 43353075560 90 in 1 BOTTLE, PLASTIC Historical