United States · FDA National Drug Code directory
Kuvan
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 68135-482_c4286a54-6e01-4444-94a0-943411790e1d
- Product NDC
- 68135-482
- Form
- POWDER, FOR SOLUTION
- Composition / generic term
- sapropterin dihydrochloride
- Labeler
- BioMarin Pharmaceutical Inc.
- Marketing category
- NDA
- Marketing start / end (source format)
- 20150527
- Source listing expiry
- 20261231
Source-listed ingredients
- SAPROPTERIN DIHYDROCHLORIDE — 500 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) · 68135-482-11
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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