xermelo

Generic: telotristat ethyl

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

Drug Facts

Product Profile

Brand Name xermelo
Generic Name telotristat ethyl
Labeler lexicon pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telotristat ethyl 250 mg/1

Manufacturer
Lexicon Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70183-125
Product ID 70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208794
Listing Expiration 2026-12-31
Marketing Start 2017-03-01

Pharmacologic Class

Classes
tryptophan hydroxylase inhibitor [epc] tryptophan hydroxylase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70183125
Hyphenated Format 70183-125

Supplemental Identifiers

RxCUI
1872453 1872458
UNII
8G388563M7

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 xermelo (source: ndc)
Generic Name telotristat ethyl (source: ndc)
Application Number NDA208794 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 250 mg tablet: white to off-white coated oval tablet with “T-E” debossed on one side and “250” debossed on the other side. Xermelo is dispensed in a monthly case for a total of 28 days of therapy. Each monthly case contains four weekly boxes. Each weekly box contains seven daily dose packs (day pack). NDC 70183-125-84: Monthly case of 84 tablets. Each child resistant daily dose pack (day pack) contains three 250 mg tablets. Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • Principal Display Panel - ShellPak Label NDC 70183-125-03 Rx Only To Open: 1. Press and hold button below 2. Pull out blister from the right XERMELO™ (telotristat ethyl) tablets 250 mg per tablet This daily dose pack contains 3 TABLETS For oral use only. As with all medications, keep out of reach of children. Principal Display Panel - ShellPak Label
  • Principal Display Panel - 28 Day Case Label NDC 70183-125-84 28 DAY CASE Rx Only 84 Tablets XERMELO™ (telotristat ethyl) tablets 250 mg per tablet Lexicon ® pharmaceuticals For oral use only. As with all medications, keep out of reach of children. Principal Display Panel - 28 Day Case Label
source: label

Packages (0)

No package records.

Ingredients (1)

telotristat ethyl (250 mg/1)

Linked Drug Pages (2)

Xermelo ndc-match (0.9) Xermelo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6", "openfda": {"unii": ["8G388563M7"], "rxcui": ["1872453", "1872458"], "spl_set_id": ["f9108ac3-ca6e-4faf-9d04-953abb64d072"], "manufacturer_name": ["Lexicon Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Xermelo", "product_id": "70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6", "dosage_form": "TABLET", "pharm_class": ["Tryptophan Hydroxylase Inhibitor [EPC]", "Tryptophan Hydroxylase Inhibitors [MoA]"], "product_ndc": "70183-125", "generic_name": "telotristat ethyl", "labeler_name": "Lexicon Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xermelo", "active_ingredients": [{"name": "TELOTRISTAT ETHYL", "strength": "250 mg/1"}], "application_number": "NDA208794", "marketing_category": "NDA", "marketing_start_date": "20170301", "listing_expiration_date": "20261231"}