Drug company (FDA labeler)
BioMarin Pharmaceutical Inc.
NDC labeler code: 68135
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
- Sapropterin dihydrochlorideKuvan, Javygtor, Zelvysia · 3 products
- Pegvaliase-pqpzPalynziq · 3 products
- GalsulfaseNaglazyme · 1 product
- Elosulfase alfaVimizim · 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 |
|---|---|---|---|
| May 24, 2018 | BLA761079 | Pegvaliase-pqpz PALYNZIQ | Biomarin Pharm |
| February 14, 2014 | BLA125460 | Elosulfase alfa VIMIZIM | Biomarin Pharm |
| December 19, 2013 | NDA205065 | Sapropterin dihydrochloride KUVAN | Biomarin Pharm |
| December 13, 2007 | NDA022181 | Sapropterin dihydrochloride KUVAN | Biomarin Pharm |
| May 31, 2005 | BLA125117 | Galsulfase NAGLAZYME | Biomarin |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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