tasimelteon

Generic: tasimelteon

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tasimelteon
Generic Name tasimelteon
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tasimelteon 20 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2548
Product ID 69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211654
Listing Expiration 2026-12-31
Marketing Start 2023-02-24

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 692382548
Hyphenated Format 69238-2548

Supplemental Identifiers

RxCUI
1490473
UPC
0369238254839
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 ANDA211654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (69238-2548-3)
source: ndc

Packages (1)

69238-2548-3 30 CAPSULE in 1 BOTTLE (69238-2548-3)

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": "071804f4-9647-4a4d-a394-55b9e976dc9f", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0369238254839"], "unii": ["SHS4PU80D9"], "rxcui": ["1490473"], "spl_set_id": ["99cb1928-e57d-4d04-87a1-38108780598a"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (69238-2548-3)", "package_ndc": "69238-2548-3", "marketing_start_date": "20230224"}], "brand_name": "Tasimelteon", "product_id": "69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f", "dosage_form": "CAPSULE", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "69238-2548", "generic_name": "Tasimelteon", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tasimelteon", "active_ingredients": [{"name": "TASIMELTEON", "strength": "20 mg/1"}], "application_number": "ANDA211654", "marketing_category": "ANDA", "marketing_start_date": "20230224", "listing_expiration_date": "20261231"}