Bayer HealthCare Pharmaceuticals Inc.
NDC labeler code: 50419
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- GadoquatraneAmbelvist · 11 products
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 7 products
- RiociguatAdempas · 5 products
- IopromideUltravist · 4 products
- LarotrectinibVitrakvi · 4 products
- LevonorgestrelKyleena, Skyla, Mirena · 3 products
- FinerenoneKerendia · 3 products
- GadobutrolGadavist, Pixxoscan · 3 products
- Drospirenone and estradiolAngeliq · 2 products
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 2 products
- SorafenibNexavar · 2 products
- NifurtimoxLampit · 2 products
- Radium ra 223 dichlorideXofigo · 1 product
- Estradiol and levonorgestrelClimara Pro · 1 product
- DarolutamideNubeqa · 1 product
- RegorafenibStivarga · 1 product
- PraziquantelBiltricide · 1 product
- SevabertinibHyrnuo · 1 product
- Gadoxetate disodiumEovist · 1 product
- ElinzanetantLynkuet · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 12, 2026 | NDA219627 | Gadoquatrane AMBELVIST | Bayer Healthcare |
| November 19, 2025 | NDA219972 | Sevabertinib HYRNUO | Bayer Healthcare |
| October 24, 2025 | NDA219469 | Elinzanetant LYNKUET | Bayer Hlthcare |
| July 9, 2021 | NDA215341 | Finerenone KERENDIA | Bayer Hlthcare |
| August 6, 2020 | NDA213464 | Nifurtimox LAMPIT | Bayer Healthcare |
| July 30, 2019 | NDA212099 | Darolutamide NUBEQA | Bayer Healthcare |
| November 26, 2018 | NDA210861 | Larotrectinib VITRAKVI | Bayer Hlthcare |
| November 26, 2018 | NDA211710 | Larotrectinib VITRAKVI | Bayer Healthcare |
| September 16, 2016 | NDA208224 | Levonorgestrel KYLEENA | Bayer Hlthcare |
| October 8, 2013 | NDA204819 | Riociguat ADEMPAS | Bayer Hlthcare |
| May 15, 2013 | NDA203971 | Radium ra 223 dichloride XOFIGO | Bayer Hlthcare |
| January 9, 2013 | NDA203159 | Levonorgestrel SKYLA | Bayer Hlthcare |
| September 27, 2012 | NDA203085 | Regorafenib STIVARGA | Bayer Hlthcare |
| March 14, 2011 | NDA201277 | Gadobutrol GADAVIST | Bayer Hlthcare |
| July 3, 2008 | NDA022090 | Gadoxetate disodium EOVIST | Bayer Hlthcare |
| December 1, 2005 | NDA021923 | Sorafenib NEXAVAR | Bayer Hlthcare |
| September 28, 2005 | NDA021355 | Drospirenone and estradiol ANGELIQ | Bayer Hlthcare |
| November 21, 2003 | NDA021258 | Estradiol and levonorgestrel CLIMARA PRO | Bayer Hlthcare |
| December 6, 2000 | NDA021225 | Levonorgestrel MIRENA | Bayer Hlthcare |
| May 10, 1995 | NDA020220 | Iopromide ULTRAVIST 150, ULTRAVIST 240, ULTRAVIST 300 | Bayer Hlthcare |
| December 22, 1994 | NDA020375 | Estradiol CLIMARA, MENOSTAR | Bayer Hlthcare |
| October 22, 1987 | NDA019537 | Ciprofloxacin CIPRO | Bayer Hlthcare |
| December 29, 1982 | NDA018714 | Praziquantel BILTRICIDE | Bayer Hlthcare |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
November 6, 2023 · Class I · Terminated · D-0145-2024 · Larotrectinib
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026