United States · FDA National Drug Code directory
sapropterin dihydrochloride
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
- 0054-0906_a92c2177-440b-4da4-92f4-e8c809ac64c5
- Product NDC
- 0054-0906
- Form
- TABLET
- Composition / generic term
- sapropterin dihydrochloride
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20251023
- Source listing expiry
- 20271231
Source-listed ingredients
- SAPROPTERIN DIHYDROCHLORIDE — 100 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 120 TABLET in 1 BOTTLE (0054-0906-23) · 0054-0906-23
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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