NDC 62856-535

BELVIQ XR

Lorcaserin Hydrochloride Hemihydrate

BELVIQ XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Eisai Inc.. The primary component is Lorcaserin Hydrochloride Hemihydrate.

• Product ID: 62856-535_3097271d-6dae-4dce-91c2-783e31678eb6
• NDC: 62856-535
• Product Type: Human Prescription Drug
• Proprietary Name: BELVIQ XR
• Generic Name: Lorcaserin Hydrochloride Hemihydrate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-15
• Marketing Category: NDA / NDA
• Application Number: NDA208524
• Labeler Name: Eisai Inc.
• Substance Name: LORCASERIN HYDROCHLORIDE HEMIHYDRATE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Serotonin-2c Receptor Agonist [EPC],Serotonin 2c Receptor Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 62856-535-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62856-535-30)

• Marketing Start Date: 2016-07-15
• Marketing End Date: 2022-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62856-535-30 [62856053530]

BELVIQ XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208524
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-15

Drug Details

Active Ingredients

Ingredient	Strength
LORCASERIN HYDROCHLORIDE HEMIHYDRATE	20 mg/1

OpenFDA Data

• SPL SET ID: 7cbbb12f-760d-487d-b789-ae2d52a3e01f
• Manufacturer:
  • Eisai Inc.
• UNII:
  • REV26SR2B4
• RxNorm Concept Unique ID - RxCUI:
  • 1300712
  • 1808552
  • 1808549
  • 1300706
• UPC Code:
  • 0362856529600
  • 0362856535304

Pharmacological Class

• Serotonin-2c Receptor Agonist [EPC]
• Serotonin 2c Receptor Agonists [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]

Medicade Reported Pricing

62856053530 BELVIQ XR 20 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "BELVIQ XR" or generic name "Lorcaserin Hydrochloride Hemihydrate"

NDC	Brand Name	Generic Name
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate
62856-529	Belviq	lorcaserin hydrochloride hemihydrate