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
72603-193_1ccf4222-e182-b467-e063-6394a90a76ec
Product NDC
72603-193
Form
POWDER, FOR SOLUTION
Composition / generic term
Sapropterin dihydrochloride
Labeler
NorthStar RxLLC
Marketing category
ANDA
Marketing start / end (source format)
20231201
Source listing expiry
20261231

Source-listed ingredients

  • SAPROPTERIN DIHYDROCHLORIDE — 100 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 30 PACKET in 1 CARTON (72603-193-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (72603-193-01) · 72603-193-30

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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