xermelo

Generic: telotristat ethyl

Labeler: tersera therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xermelo
Generic Name telotristat ethyl
Labeler tersera therapeutics llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telotristat ethyl 250 mg/1

Manufacturer
TerSera Therapeutics LLC

Identifiers & Regulatory

Product NDC 70720-125
Product ID 70720-125_ba59d050-c350-492f-a421-f4b64f6fc60e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208794
Listing Expiration 2026-12-31
Marketing Start 2020-10-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70720125
Hyphenated Format 70720-125

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
  • 4 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70720-125-85 4 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK

Ingredients (1)

telotristat ethyl (250 mg/1)

Linked Drug Pages (1)

Xermelo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ba59d050-c350-492f-a421-f4b64f6fc60e", "openfda": {"unii": ["8G388563M7"], "rxcui": ["1872453", "1872458"], "spl_set_id": ["a4ac9d62-887c-4c8f-b04d-a5f31cec7c86"], "manufacturer_name": ["TerSera Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOX in 1 CASE (70720-125-85)  / 1 BLISTER PACK in 1 BOX (70720-125-22)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "70720-125-85", "marketing_start_date": "20211001"}], "brand_name": "Xermelo", "product_id": "70720-125_ba59d050-c350-492f-a421-f4b64f6fc60e", "dosage_form": "TABLET", "pharm_class": ["Tryptophan Hydroxylase Inhibitor [EPC]", "Tryptophan Hydroxylase Inhibitors [MoA]"], "product_ndc": "70720-125", "generic_name": "telotristat ethyl", "labeler_name": "TerSera Therapeutics LLC", "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": "20201005", "listing_expiration_date": "20261231"}