Prescription drug · NDA
Xermelo (Telotristat ethyl) NDC 70183-125
Telotristat ethyl 250 mg/1 · Tablet · Oral · Lexicon Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Xermelo
- Generic name (nonproprietary)
- telotristat ethyl
- Active ingredients
- Telotristat ethyl — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lexicon Pharmaceuticals, Inc.NDC labeler code 70183
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208794
- Marketing start
- Listing expires
- Other FDA classes
- Tryptophan Hydroxylase Inhibitors (Mechanism)
- Identifiers
- Product ID 70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6SPL ID 4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6SPL set ID f9108ac3-ca6e-4faf-9d04-953abb64d072RxCUI 1872453, 1872458UNII 8G388563M7
- Pharmacologic class
- Tryptophan Hydroxylase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70183-125
- What is NDC 70183-125?
- 70183-125 is the product NDC for Xermelo (telotristat ethyl), Telotristat ethyl 250 mg/1 tablet, listed with the FDA by Lexicon Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Xermelo (Telotristat ethyl).
- What is the active ingredient?
- Telotristat ethyl.
- Who is the labeler?
- Lexicon Pharmaceuticals, Inc., NDC labeler code 70183. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xermelo?
- 2 other product NDCs are listed under this name. See all Xermelo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xermelo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xermelotelotristat ethyl | Telotristat ethyl 250 mg/1 | TabletOral | TerSera Therapeutics LLC | 70720-125 | 70720-0125-85 |
Other NDCs under NDA 208794
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xermelotelotristat ethyl | Telotristat ethyl 250 mg/1 | TabletOral | TerSera Therapeutics LLC | 70720-125 |