Prescription drug · NDA
Xermelo (Telotristat ethyl) NDC 70720-125
Telotristat ethyl 250 mg/1 · Tablet · Oral · TerSera Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70720-125-85 | 70720012585 | 4 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACKMarketed from Oct 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xermelo
- Generic name (nonproprietary)
- telotristat ethyl
- Active ingredients
- Telotristat ethyl — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TerSera Therapeutics LLCNDC labeler code 70720
- 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 70720-125_8643b325-c079-4319-b751-223180291f0aSPL ID 8643b325-c079-4319-b751-223180291f0aSPL set ID a4ac9d62-887c-4c8f-b04d-a5f31cec7c86RxCUI 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.
- NDC on a medical claim
N470720012585followed by a unit qualifier and the quantityPackage 70720-0125-85. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
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 70720-125
- What is NDC 70720-125?
- 70720-125 is the product NDC for Xermelo (telotristat ethyl), Telotristat ethyl 250 mg/1 tablet, listed with the FDA by TerSera Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xermelo (Telotristat ethyl).
- What is the active ingredient?
- Telotristat ethyl.
- Who is the labeler?
- TerSera Therapeutics LLC, NDC labeler code 70720. 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 | Lexicon Pharmaceuticals, Inc. | 70183-125 | — |
| Xermelotelotristat ethyl | Telotristat ethyl 250 mg/1 | TabletOral | Lexicon Pharmaceuticals, Inc. | 70183-125 | — |
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 | Lexicon Pharmaceuticals, Inc. | 70183-125 |
| Xermelotelotristat ethyl | Telotristat ethyl 250 mg/1 | TabletOral | Lexicon Pharmaceuticals, Inc. | 70183-125 |