NDC 70183-125
Xermelo
Telotristat Ethyl
Xermelo is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lexicon Pharmaceuticals, Inc.. The primary component is Telotristat Ethyl.
| Product ID | 70183-125_12e74795-1e89-4f3e-a162-01ab941aca0b |
| NDC | 70183-125 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Xermelo |
| Generic Name | Telotristat Ethyl |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-03-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208794 |
| Labeler Name | Lexicon Pharmaceuticals, Inc. |
| Substance Name | TELOTRISTAT ETHYL |
| Active Ingredient Strength | 250 mg/1 |
| Pharm Classes | Tryptophan Hydroxylase Inhibitor [EPC],Tryptophan Hydroxylase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 70183-125-85
4 BOX in 1 CASE (70183-125-85) > 4 BLISTER PACK in 1 BOX (70183-125-22) > 21 TABLET in 1 BLISTER PACK
| Marketing Start Date | 2021-02-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70183-125-21 [70183012521]
Xermelo TABLET
| Marketing Category | NDA |
| Application Number | NDA208794 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-03-01 |
NDC 70183-125-84 [70183012584]
Xermelo TABLET
| Marketing Category | NDA |
| Application Number | NDA208794 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-01 |
NDC 70183-125-03 [70183012503]
Xermelo TABLET
| Marketing Category | NDA |
| Application Number | NDA208794 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-03-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TELOTRISTAT ETHYL | 250 mg/1 |
OpenFDA Data
| SPL SET ID: | f11c21f8-f725-445e-b38e-1e4c5b05bcc6 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Tryptophan Hydroxylase Inhibitor [EPC]
- Tryptophan Hydroxylase Inhibitors [MoA]
NDC Crossover Matching brand name "Xermelo" or generic name "Telotristat Ethyl"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70183-125 | Xermelo | telotristat ethyl |
| 70720-125 | Xermelo | telotristat ethyl |
Trademark Results [Xermelo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XERMELO 87320213 not registered Live/Pending |
Lexicon Pharmaceuticals, Inc. 2017-01-31 |
 XERMELO 86013323 5200148 Live/Registered |
Lexicon Pharmaceuticals, Inc. 2013-07-17 |
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