Data / Drug companies / BioMarin Pharmaceutical Inc.
BioMarin Pharmaceutical Inc.: 19 products in the FDA NDC directory, labeler code 68135
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
BioMarin Pharmaceutical Inc. (labeler code 68135) lists 19 products in the FDA National Drug Code Directory, covering 6 finished drugs by generic name. By type: 12 prescription drugs, 7 drugs for further processing. Its main marketing category is drugs for further processing. The newest product started marketing on November 19, 2021.
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- Labeler code
- 68135
- Products in commercial distribution
- 19
- Packages
- 20
- Finished drugs by generic name
- 6
- Prescription products
- 12
- Over the counter products
- 0
- Flagged as original packager
- 12 of 12 products that carry the flag
- Started marketing in the last 12 months
- 0
- Earliest marketing start
- April 30, 2003
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Drugs for further processing | 7 | 36.8% |
| Biologics (BLA) | 6 | 31.6% |
| New drug applications (NDA) | 6 | 31.6% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 12 | 63.2% |
| Drugs for further processing | 7 | 36.8% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Pegvaliase-pqpz | 3 | 1 |
| Vosoritide | 3 | 1 |
| Sapropterin dihydrochloride | 3 | 10 |
| Elosulfase alfa | 1 | 1 |
| Galsulfase | 1 | 1 |
| Cerliponase alfa | 1 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 6 | 31.6% |
| Kit | 4 | 21.1% |
| Injection, solution, concentrate | 4 | 21.1% |
| Solution | 2 | 10.5% |
| Powder, for solution | 2 | 10.5% |
| Tablet | 1 | 5.3% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Phenylalanine Metabolizing Enzyme | 3 |
| Phenylalanine Hydroxylase Activator | 3 |
| Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme | 2 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| VOXZOGO 1.2mg | 68135-181 | Kit | New drug applications (NDA) | November 19, 2021 |
| VOXZOGO 0.56mg | 68135-119 | Kit | New drug applications (NDA) | November 19, 2021 |
| VOXZOGO 0.4mg | 68135-082 | Kit | New drug applications (NDA) | November 19, 2021 |
| Vosoritide | 68135-062 | Injection, solution, concentrate | Drugs for further processing | November 19, 2021 |
| Cerliponase alfa | 68135-502 | Injection, solution | Drugs for further processing | January 17, 2020 |
| Palynziq | 68135-756 | Injection, solution | Biologics (BLA) | May 24, 2018 |
| Palynziq | 68135-673 | Injection, solution | Biologics (BLA) | May 24, 2018 |
| Pegvaliase-pqpz | 68135-117 | Injection, solution | Drugs for further processing | May 24, 2018 |
| Pegvaliase-pqpz | 68135-060 | Injection, solution | Drugs for further processing | May 24, 2018 |
| Palynziq | 68135-058 | Injection, solution | Biologics (BLA) | May 24, 2018 |
| Brineura | 68135-811 | Kit | Biologics (BLA) | April 27, 2017 |
| Kuvan | 68135-482 | Powder, for solution | New drug applications (NDA) | May 27, 2015 |
| Kuvan | 68135-301 | Powder, for solution | New drug applications (NDA) | February 21, 2014 |
| Elosulfase alfa | 68135-100 | Injection, solution, concentrate | Drugs for further processing | February 14, 2014 |
| Vimizim | 68135-100 | Injection, solution, concentrate | Biologics (BLA) | February 14, 2014 |
| Kuvan | 68135-300 | Tablet | New drug applications (NDA) | December 14, 2007 |
| Galsulfase | 68135-020 | Solution | Drugs for further processing | June 9, 2005 |
| Naglazyme | 68135-020 | Solution | Biologics (BLA) | June 9, 2005 |
| Laronidase | 68135-000 | Injection, solution, concentrate | Drugs for further processing | April 30, 2003 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.