FDA.reportPublic FDA data

NDC 73289-0070-1 - ZELVYSIA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73289-0070
Requested NDC
73289-0070-1
Package NDCs from labels
73289-0070-1, 73289-0070-2
Manufacturer
Aucta Pharmaceuticals, Inc.
Effective date
2025-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZELVYSIA - Aucta Pharmaceuticals, Inc.Aucta Pharmaceuticals, Inc.2025-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73289-0070-1ZELVYSIA1 in 1 PACKETPOWDER, FOR SOLUTION11
73289-0070-2ZELVYSIA30 in 1 CARTONPOWDER, FOR SOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73289-0070ZELVYSIA (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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73289-0070-1EA - Each73289-00703f3cf0b8-3972-4fec-8b57-2a0a6834d46412025-10-14
73289-0070-2EA - Each73289-007073a0e219-fdd8-4d3e-a111-ea373cd5f76f12025-10-14

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 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDEHikma Pharmaceuticals USA Inc.c4d92cce-e899-4f14-b19c-5e17f99222152026-08-06Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLC2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 1653217
unii: RG277LF5B3
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLCeafec3a2-4f29-4afa-8728-a62b34cefd182026-04-17Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.3f0d6820-ff59-40c0-882f-aeea2dd1d1ad2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.ec8ea96c-8ec1-4301-a85d-d59562e548ca2026-02-24Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDETRUPHARMA, LLC39f1d020-4359-401b-88a8-ed25eaa40b452026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEMicro Labs Limited907e24c4-3337-4aee-b789-276e37a85cd82026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEAurobindo Pharma Limited11ee25bc-f501-4f9d-b63d-63b2eee0147e2025-06-10Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
ZELVYSIASAPROPTERIN DIHYDROCHLORIDEAucta Pharmaceuticals, Inc.8de84882-dd24-46f2-8416-5e492d4275d12025-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA218645
ndc (package): 73289-0071-2
ndc (package): 73289-0071-1
ndc (package): 73289-0070-2
ndc (package): 73289-0070-1
ndc (product): 73289-0071
ndc (product): 73289-0070
ndc11 (package): 73289007001
rxcui: 2712691
rxcui: 2712689
rxcui: 1653217
rxcui: 1111018
spl id: 34007201-2d47-96fd-e063-6394a90a6327
spl set id: 8de84882-dd24-46f2-8416-5e492d4275d1
unii: RG277LF5B3
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCa64a50ba-e3da-4227-9bce-87101d60409e2025-01-06Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inceecdd8c7-5f8a-0af1-793a-db2e2ba0f4912024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 1653217
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Incd9f3723f-bf7d-9a72-2ef9-41c5508d6ab42024-10-21Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inc1590afa1-baa4-70e5-5a3b-468401c710442024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1111018
unii: RG277LF5B3
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCb3999f74-920d-4444-afa7-f4211e4eb4312024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLC6b2172e4-42fc-42fe-b1ad-9d6a974d43432020-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1111018
unii: RG277LF5B3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.