NDC 43068-220

Hetlioz

Tasimelteon

Hetlioz is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Vanda Pharmaceuticals Inc.. The primary component is Tasimelteon.

• Product ID: 43068-220_046bf85f-3017-415f-a709-4d849c8d2744
• NDC: 43068-220
• Product Type: Human Prescription Drug
• Proprietary Name: Hetlioz
• Generic Name: Tasimelteon
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-04
• Marketing Category: NDA / NDA
• Application Number: NDA205677
• Labeler Name: Vanda Pharmaceuticals Inc.
• Substance Name: TASIMELTEON
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43068-220-01

30 CAPSULE in 1 BOTTLE (43068-220-01)

• Marketing Start Date: 2014-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43068-220-01 [43068022001]

Hetlioz CAPSULE

• Marketing Category: NDA
• Application Number: NDA205677
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-04

Drug Details

Active Ingredients

Ingredient	Strength
TASIMELTEON	20 mg/1

OpenFDA Data

• SPL SET ID: ca4a9b63-708e-49e9-8f9b-010625443b90
• Manufacturer:
  • Vanda Pharmaceuticals Inc.
• UNII:
  • SHS4PU80D9
• RxNorm Concept Unique ID - RxCUI:
  • 1491624
  • 1490473
• UPC Code:
  • 0343068220011

Pharmacological Class

• Melatonin Receptor Agonist [EPC]
• Melatonin Receptor Agonists [MoA]

NDC Crossover Matching brand name "Hetlioz" or generic name "Tasimelteon"

NDC	Brand Name	Generic Name
43068-220	Hetlioz	tasimelteon
43068-304	Hetlioz	tasimelteon
0480-4490	Tasimelteon	Tasimelteon