tasimelteon

Generic: tasimelteon

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tasimelteon
Generic Name tasimelteon
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

tasimelteon 20 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-4490
Product ID 0480-4490_742d1ad6-c92e-4d2c-9d23-c5616751c5dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211601
Listing Expiration 2026-12-31
Marketing Start 2022-12-29

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 04804490
Hyphenated Format 0480-4490

Supplemental Identifiers

RxCUI
1490473
UPC
0304804490563
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 ANDA211601 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56)
source: ndc

Packages (1)

0480-4490-56 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56)

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": "742d1ad6-c92e-4d2c-9d23-c5616751c5dc", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0304804490563"], "unii": ["SHS4PU80D9"], "rxcui": ["1490473"], "spl_set_id": ["ce5a2fa3-ed54-422d-96c2-1821496eb32f"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56)", "package_ndc": "0480-4490-56", "marketing_start_date": "20221229"}], "brand_name": "Tasimelteon", "product_id": "0480-4490_742d1ad6-c92e-4d2c-9d23-c5616751c5dc", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "0480-4490", "generic_name": "Tasimelteon", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tasimelteon", "active_ingredients": [{"name": "TASIMELTEON", "strength": "20 mg/1"}], "application_number": "ANDA211601", "marketing_category": "ANDA", "marketing_start_date": "20221229", "listing_expiration_date": "20261231"}