Home NDC 52817-850 Sapropterin Dihydrochloride
Product NDC 52817-850
11-digit product format 528170850
Labeler code 52817
Product ID 52817-850_4b1fe6f7-f641-ec9a-e063-6394a90a4e04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sapropterin Dihydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler TRUPHARMA, LLC
Application ANDA216432
Marketing category ANDA
Marketing start 2026-01-30
Substance SAPROPTERIN DIHYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216432-001 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB 2025-09-03 A216432-002 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB 2025-09-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216432-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216432-002 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2025-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216432-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216432-002 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2025-09-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216432-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB 2025-09-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216432-002 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB 2025-09-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sapropterin Dihydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RG277LF5B3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111018 Internal RxNorm lookup 1653217 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52817-850-01 Sapropterin Dihydrochloride 1 in 1 POUCH POWDER, FOR SOLUTION 1 2 52817-850-30 Sapropterin Dihydrochloride 30 in 1 CARTON POWDER, FOR SOLUTION 30 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 52817-850-01 52817085001 1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01) 2026-01-30 No No Current 52817-850-30 52817085030 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30) 2026-01-30 No No Current