Home NDC 0615-7505 Risperidone
Product NDC 0615-7505
11-digit product format 006157505
Labeler code 0615
Product ID 0615-7505_cb1c057c-97ba-43a2-aceb-b2d096af0f6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA076288
Marketing category ANDA
Marketing start 2008-09-17
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 0 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 1 · 48 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 34