tasimelteon

Generic: tasimelteon

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tasimelteon
Generic Name tasimelteon
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tasimelteon 20 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4665
Product ID 60505-4665_5fdd9cbd-360f-3787-3863-c1172763840f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211607
Listing Expiration 2026-12-31
Marketing Start 2024-01-05

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 605054665
Hyphenated Format 60505-4665

Supplemental Identifiers

RxCUI
1490473
UPC
0360505466535
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 tasimelteon (source: ndc)
Generic Name tasimelteon (source: ndc)
Application Number ANDA211607 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (60505-4665-3)
  • 90 CAPSULE in 1 BOTTLE (60505-4665-9)
source: ndc

Packages (2)

60505-4665-3 30 CAPSULE in 1 BOTTLE (60505-4665-3) 60505-4665-9 90 CAPSULE in 1 BOTTLE (60505-4665-9)

Ingredients (1)

tasimelteon (20 mg/1)

Linked Drug Pages (1)

Tasimelteon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5fdd9cbd-360f-3787-3863-c1172763840f", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0360505466535"], "unii": ["SHS4PU80D9"], "rxcui": ["1490473"], "spl_set_id": ["46b09064-a675-92d5-24a7-dac0410f77ae"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60505-4665-3)", "package_ndc": "60505-4665-3", "marketing_start_date": "20240105"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (60505-4665-9)", "package_ndc": "60505-4665-9", "marketing_start_date": "20240105"}], "brand_name": "Tasimelteon", "product_id": "60505-4665_5fdd9cbd-360f-3787-3863-c1172763840f", "dosage_form": "CAPSULE", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "60505-4665", "generic_name": "Tasimelteon", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tasimelteon", "active_ingredients": [{"name": "TASIMELTEON", "strength": "20 mg/1"}], "application_number": "ANDA211607", "marketing_category": "ANDA", "marketing_start_date": "20240105", "listing_expiration_date": "20261231"}