Home NDC 55648-557 RISPERIDONE
Product NDC 55648-557
11-digit product format 556480557
Labeler code 55648
Product ID 55648-557_aaa62d0c-37d5-40a9-8940-2f2b7397197f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RISPERIDONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler WOCKHARDT LIMITED
Application ANDA078871
Marketing category ANDA
Marketing start 2008-10-09
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 2 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078871-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 A078871-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 A078871-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 A078871-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 A078871-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 A078871-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09
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 · 258 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 2026-09-14 22:38:34 2026-08 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078871-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078871-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-09 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 55648-557-01 RISPERIDONE 30 in 1 BOTTLE TABLET, FILM COATED 30 2 55648-557-02 RISPERIDONE 500 in 1 BOTTLE TABLET, FILM COATED 500 2 55648-557-03 RISPERIDONE 100 in 1 CARTON TABLET, FILM COATED 100 2 55648-557-03 RISPERIDONE 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 55648-557-04 RISPERIDONE 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-557 RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 5 package rows 20121019_e92a97ef-0fe3-40b1-a938-373293a75255.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-557-01 55648055701 30 in 1 BOTTLE Historical 55648-557-02 55648055702 500 in 1 BOTTLE Historical 55648-557-03 55648055703 100 in 1 CARTON Historical 55648-557-04 55648055704 60 in 1 BOTTLE Historical