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
31722-047_4c45ff1f-15f2-2237-e063-6294a90a0aca
Product NDC
31722-047
Form
POWDER, FOR SOLUTION
Composition / generic term
Sapropterin dihydrochloride
Labeler
Camber Pharmaceuticals, Inc.
Marketing category
ANDA
Marketing start / end (source format)
20220818
Source listing expiry
20271231

Source-listed ingredients

  • SAPROPTERIN DIHYDROCHLORIDE — 100 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) · 31722-047-30
  • 1 PACKET in 1 CARTON (31722-047-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) · 31722-047-31

Source and coverage

Open FDA National Drug Code directory

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.

Browse United States records →
Sapropterin dihydrochloride — United States | Molindra Medicines