BELVIQ XR

Product NDC: 62856-535
Requested package NDC: 62856-535-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62856-535	62856-535-30	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62856-535-30	EA - Each	62856-535	91c8ad21-fcdc-4015-b0c7-612508037a0d	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORCASERIN HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	REV26SR2B4	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
LORCASERIN	ACTIVE MOIETY	637E494O0Z	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BELVIQ (LORCASERIN HYDROCHLORIDE HEMIHYDRATE) TABLET [EISAI INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
REV26SR2B4	LORCASERIN HYDROCHLORIDE HEMIHYDRATE	856681-05-5	LORCASERIN HYDROCHLORIDE HEMIHYDRATE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Belviq	Eisai Inc.	2018-04-29	HUMAN PRESCRIPTION DRUG LABEL	23
BELVIQ XR Extended Release Extended Release	Eisai Inc.	2016-07-25	HUMAN PRESCRIPTION DRUG LABEL	1