Home NDC 62856-535 BELVIQ XR
Product NDC 62856-535
11-digit product format 628560535
Labeler code 62856
Product ID 62856-535_56a5ecbb-948c-4dda-b6ce-6b0086f2e293
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lorcaserin hydrochloride hemihydrate
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Eisai Inc.
Application NDA208524
Marketing category NDA
Marketing start 2016-07-15
Marketing end 2022-05-31
Substance LORCASERIN HYDROCHLORIDE HEMIHYDRATE
Active strength 20 mg/1
Pharmacologic classes Serotonin-2c Receptor Agonist [EPC],Serotonin 2c Receptor Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
DEA schedule CIV
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62856-535-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62856-535-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62856-535-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62856-535-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62856-535-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62856-535-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62856-535-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62856-535-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62856-535-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62856-535-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62856-535-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62856-535-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2016-07-15 74a2ff9319b5…2021-03-12 10:30 UTC 2021-03 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2016-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2016-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208524-001 BELVIQ XR 20MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2016-07-15 ea99ee380514…
Observed Orange Book patent history# Patent history page 1 of 8 · 305 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N208524-001 6953787 2023-04-10 U-1254 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 6953787 2023-04-10 U-1255 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 6953787 2023-04-10 U-1253 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 6953787 2023-04-10 U-1252 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7514422 2023-04-10 U-1254 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7514422 2023-04-10 U-1255 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7514422 2023-04-10 U-1252 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7514422 2023-04-10 U-1253 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7977329 2023-04-10 U-1254 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7977329 2023-04-10 U-1252 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7977329 2023-04-10 U-1253 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 7977329 2023-04-10 U-1255 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8207158 2023-04-10 U-1254 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8207158 2023-04-10 U-1255 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8207158 2023-04-10 U-1252 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8207158 2023-04-10 U-1253 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8273734 2023-04-10 U-1254 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8273734 2023-04-10 U-1255 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8367657 2023-04-10 U-1252 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8367657 2023-04-10 U-1254 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8367657 2023-04-10 U-1253 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8367657 2023-04-10 U-1255 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8546379 2023-04-10 U-1252 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8546379 2023-04-10 U-1255 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8546379 2023-04-10 U-1254 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8546379 2023-04-10 U-1253 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8575149 2023-04-10 U-1452 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8946207 2024-06-16 Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8697686 2025-12-20 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8980881 2025-12-20 U-1254 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8980881 2025-12-20 U-1255 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8980881 2025-12-20 U-1253 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8980881 2025-12-20 U-1252 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 8168624 2029-04-18 Drug substance, Drug product 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 10226471 2031-08-31 Drug product 2019-04-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 9770455 2031-08-31 U-2110 2017-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 9169213 2032-12-06 U-1885 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 9169213 2032-12-06 U-1887 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 9169213 2032-12-06 U-1884 2016-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208524-001 9169213 2032-12-06 U-1886 2016-08-12 74a2ff9319b5…
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62856-535-30 62856053530 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62856-535-30) 2016-07-15 2022-05-31 No No Current