NDC 50419-393 – Vitrakvi
Larotrectinib 20 mg/mL · Solution, Concentrate · Oropharyngeal
Product NDC50419-393
Product details
- Brand name
- Vitrakvi
- Generic name
- Larotrectinib
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Dosage form
- Solution, Concentrate
- Route
- Oropharyngeal
- Marketing category
- NDA · NDA211710
- Marketed since
- December 6, 2022
- Listing expires
- December 31, 2027
- Pharmacologic class
- Kinase Inhibitor
Active ingredients
- Larotrectinib 20 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 50419-393-03 | 2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02) | Dec 6, 2022 |
Recalls mentioning this NDC
- D-0145-2024 Dec 6, 2023 · Class I
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Other Vitrakvi products
- 50419-392 Larotrectinib 20 mg/mL · Solution, Concentrate · Bayer HealthCare Pharmaceuticals Inc.
- 50419-390 Larotrectinib 25 mg/1 · Capsule · Bayer HealthCare Pharmaceuticals Inc.
- 50419-391 Larotrectinib 100 mg/1 · Capsule · Bayer HealthCare Pharmaceuticals Inc.
- 71777-390 Larotrectinib 25 mg/1 · Capsule · Loxo Oncology, Inc.
- 71777-391 Larotrectinib 100 mg/1 · Capsule · Loxo Oncology, Inc.
- 71777-392 Larotrectinib 20 mg/mL · Solution · Loxo Oncology, Inc.