NDC 71779-115
Copiktra
Duvelisib
Copiktra is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Verastem, Inc.. The primary component is Duvelisib.
| Product ID | 71779-115_6d6a2523-d478-499c-961e-4b99247c204e |
| NDC | 71779-115 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Copiktra |
| Generic Name | Duvelisib |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-09-25 |
| Marketing Category | NDA / NDA |
| Application Number | NDA211155 |
| Labeler Name | Verastem, Inc. |
| Substance Name | DUVELISIB |
| Active Ingredient Strength | 15 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 71779-115-01
56 CAPSULE in 1 BOTTLE (71779-115-01)
| Marketing Start Date | 2018-09-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 71779-115-02 [71779011502]
Copiktra CAPSULE
| Marketing Category | NDA |
| Application Number | NDA211155 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-25 |
NDC 71779-115-01 [71779011501]
Copiktra CAPSULE
| Marketing Category | NDA |
| Application Number | NDA211155 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-25 |
NDC 71779-115-03 [71779011503]
Copiktra CAPSULE
| Marketing Category | NDA |
| Application Number | NDA211155 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-25 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DUVELISIB | 15 mg/1 |
OpenFDA Data
| SPL SET ID: | 47547f93-489c-4298-aeea-d6a37ca6cb1d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "Copiktra" or generic name "Duvelisib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 71779-115 | Copiktra | duvelisib |
| 71779-125 | Copiktra | duvelisib |
| 73116-115 | COPIKTRA | duvelisib |
| 73116-125 | COPIKTRA | duvelisib |
| 73116-215 | COPIKTRA | duvelisib |
| 73116-225 | COPIKTRA | duvelisib |
Trademark Results [Copiktra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COPIKTRA 88214907 not registered Live/Pending |
Infinity Pharmaceuticals, Inc. 2018-12-03 |
 COPIKTRA 87041688 5643918 Live/Registered |
Infinity Pharmaceuticals, Inc. 2016-05-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.