Home NDC 73289-0070 ZELVYSIA
Product NDC 73289-0070
11-digit product format 732890070
Labeler code 73289
Product ID 73289-0070_34007201-2d47-96fd-e063-6394a90a6327
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SAPROPTERIN DIHYDROCHLORIDE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Aucta Pharmaceuticals, Inc.
Application ANDA218645
Marketing category ANDA
Marketing start 2025-04-29
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 2026-12-31
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 A218645-001 ZELVYSIA SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB 2025-04-29 A218645-002 ZELVYSIA SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB 2025-04-29
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 A218645-001 ZELVYSIA 100MG/PACKET POWDER / ORAL AB 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218645-002 ZELVYSIA 500MG/PACKET POWDER / ORAL AB 2025-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218645-001 ZELVYSIA 100MG/PACKET POWDER / ORAL AB 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218645-002 ZELVYSIA 500MG/PACKET POWDER / ORAL AB 2025-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218645-001 ZELVYSIA 100MG/PACKET POWDER / ORAL AB 2025-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218645-002 ZELVYSIA 500MG/PACKET POWDER / ORAL AB 2025-04-29 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218645-001 ZELVYSIA 100MG/PACKET FOR SOLUTION / ORAL AB 2025-04-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218645-002 ZELVYSIA 500MG/PACKET FOR SOLUTION / ORAL AB 2025-04-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ZELVYSIA
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111018 Internal RxNorm lookup 1653217 Internal RxNorm lookup 2712689 Internal RxNorm lookup 2712691 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 73289-0070-1 ZELVYSIA 1 in 1 PACKET POWDER, FOR SOLUTION 1 1 73289-0070-2 ZELVYSIA 30 in 1 CARTON POWDER, FOR SOLUTION 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73289-0070 ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [AUCTA PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20250502_8de84882-dd24-46f2-8416-5e492d4275d1.zip
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 Units Marketing start Sample Exclude flag Status 73289-0070-1 73289007001 1 in 1 PACKET Historical 73289-0070-2 73289007002 30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1) 30 packet 2025-04-29 No No Current