hetlioz

Generic: tasimelteon

Labeler: vanda pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hetlioz
Generic Name tasimelteon
Labeler vanda pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tasimelteon 20 mg/1

Manufacturer
Vanda Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 43068-220
Product ID 43068-220_3248eef5-6bad-4844-a6f9-2f5fddd39c8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205677
Listing Expiration 2026-12-31
Marketing Start 2014-04-04

Pharmacologic Class

Established (EPC)
melatonin receptor agonist [epc]
Mechanism of Action
melatonin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43068220
Hyphenated Format 43068-220

Supplemental Identifiers

RxCUI
1490473 1491624 2468312 2468316
UNII
SHS4PU80D9
NUI
N0000175743 N0000000250

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hetlioz (source: ndc)
Generic Name tasimelteon (source: ndc)
Application Number NDA205677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (43068-220-01)
source: ndc

Packages (1)

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

Ingredients (1)

tasimelteon (20 mg/1)

Linked Drug Pages (1)

Hetlioz, Hetlioz LQ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3248eef5-6bad-4844-a6f9-2f5fddd39c8d", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["SHS4PU80D9"], "rxcui": ["1490473", "1491624", "2468312", "2468316"], "spl_set_id": ["ca4a9b63-708e-49e9-8f9b-010625443b90"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Vanda Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (43068-220-01)", "package_ndc": "43068-220-01", "marketing_start_date": "20140404"}], "brand_name": "Hetlioz", "product_id": "43068-220_3248eef5-6bad-4844-a6f9-2f5fddd39c8d", "dosage_form": "CAPSULE", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "43068-220", "generic_name": "tasimelteon", "labeler_name": "Vanda Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hetlioz", "active_ingredients": [{"name": "TASIMELTEON", "strength": "20 mg/1"}], "application_number": "NDA205677", "marketing_category": "NDA", "marketing_start_date": "20140404", "listing_expiration_date": "20261231"}