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NDC 50419-0393-03 VITRAKVI 20 mg/mL Details
VITRAKVI 20 mg/mL
VITRAKVI is a OROPHARYNGEAL SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayer HealthCare Pharmaceuticals Inc.. The primary component is LAROTRECTINIB.
MedlinePlus Drug Summary
Larotrectinib is used to treat a certain type of solid tumors in adults, children, and infants 4 weeks of age and older that have spread to other parts of the body or cannot be treated successfully with surgery. This medication is used only if there are no other treatments available and the tumors have worsened after receiving other treatments. Larotrectinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that tells the cancer cells to multiply. This may help slow the growth of tumors.
Related Packages: 50419-0393-03Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Larotrectinib
Product Information
| NDC | 50419-0393 |
|---|---|
| Product ID | 50419-393_3e340753-c526-4748-9e8a-d99e3511d7ef |
| Associated GPIs | |
| GCN Sequence Number | 079308 |
| GCN Sequence Number Description | larotrectinib sulfate SOLUTION 20 MG/ML ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 45789 |
| HICL Sequence Number | 045494 |
| HICL Sequence Number Description | LAROTRECTINIB SULFATE |
| Brand/Generic | Brand |
| Proprietary Name | VITRAKVI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LAROTRECTINIB |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION, CONCENTRATE |
| Route | OROPHARYNGEAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | LAROTRECTINIB |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211710 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50419-0393-03 (50419039303)
| NDC Package Code | 50419-393-03 |
|---|---|
| Billing NDC | 50419039303 |
| Package | 2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02) |
| Marketing Start Date | 2022-12-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |