FDA.reportPublic FDA data

ZELVYSIA

Product NDC
73289-0071
11-digit product format
732890071
Labeler code
73289
Product ID
73289-0071_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
500 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

Additional Listing Data#

Finished product
Yes
Brand name base
ZELVYSIA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1111018, 1653217, 2712689, 2712691

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73289-0071-1ZELVYSIA1 in 1 PACKETPOWDER, FOR SOLUTION11
73289-0071-2ZELVYSIA30 in 1 CARTONPOWDER, FOR SOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73289-0071-1EA - Each73289-007167d41fef-d0f0-4503-864b-05f5fef2053512025-10-14
73289-0071-2EA - Each73289-007107fe2be5-d29a-4b6f-89f9-4ccc0af26e6212025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73289-0071ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [AUCTA PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250502_8de84882-dd24-46f2-8416-5e492d4275d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionPSN8de84882-dd24-46f2-8416-5e492d4275d11
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSN8de84882-dd24-46f2-8416-5e492d4275d11
2712689Zelvysia 100 MG Powder for Oral SolutionPSN8de84882-dd24-46f2-8416-5e492d4275d11
2712691Zelvysia 500 MG Powder for Oral SolutionPSN8de84882-dd24-46f2-8416-5e492d4275d11
2712689sapropterin dihydrochloride 100 MG Powder for Oral Solution [Zelvysia]SBD8de84882-dd24-46f2-8416-5e492d4275d11
2712691sapropterin dihydrochloride 500 MG Powder for Oral Solution [Zelvysia]SBD8de84882-dd24-46f2-8416-5e492d4275d11
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionSCD8de84882-dd24-46f2-8416-5e492d4275d11
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCD8de84882-dd24-46f2-8416-5e492d4275d11
2712689Zelvysia 100 MG Powder for Oral SolutionSY8de84882-dd24-46f2-8416-5e492d4275d11
2712691Zelvysia 500 MG Powder for Oral SolutionSY8de84882-dd24-46f2-8416-5e492d4275d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73289-0071-1732890071011 in 1 PACKETHistorical
73289-0071-27328900710230 PACKET in 1 CARTON (73289-0071-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1) 30 packet2025-04-29NoNoHistorical