Lundbeck Pharmaceuticals LLC
NDC labeler code: 67386
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
- DroxidopaNorthera · 3 products
- ClobazamSympazan, Onfi · 3 products
- VigabatrinSabril, Vigadrone, Vigafyde · 2 products
- TetrabenazineXenazine · 2 products
- Eptinezumab-jjmrVyepti · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 21, 2020 | BLA761119 | Eptinezumab-jjmr VYEPTI | Lundbeck Seattle BioPharmaceuticals, Inc. |
| February 18, 2014 | NDA203202 | Droxidopa NORTHERA | Lundbeck Na Ltd |
| December 14, 2012 | NDA203993 | Clobazam ONFI | Lundbeck Pharms LLC |
| October 21, 2011 | NDA202067 | Clobazam ONFI | Lundbeck Pharms LLC |
| August 21, 2009 | NDA020427 | Vigabatrin SABRIL | Lundbeck Pharms LLC |
| August 21, 2009 | NDA022006 | Vigabatrin SABRIL | Lundbeck Pharms LLC |
| August 15, 2008 | NDA021894 | Tetrabenazine XENAZINE | Bausch |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
August 17, 2023 · Class III · Completed · D-1142-2023 · Vigabatrin
Cross contamination with other products
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
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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