zelvysia

Generic: sapropterin dihydrochloride

Labeler: aucta pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zelvysia
Generic Name sapropterin dihydrochloride
Labeler aucta pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

sapropterin dihydrochloride 100 mg/1

Manufacturer
Aucta Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 73289-0070
Product ID 73289-0070_34007201-2d47-96fd-e063-6394a90a6327
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218645
Listing Expiration 2026-12-31
Marketing Start 2025-04-29

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] p-glycoprotein inhibitors [moa] phenylalanine hydroxylase activator [epc] phenylalanine hydroxylase activators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 732890070
Hyphenated Format 73289-0070

Supplemental Identifiers

RxCUI
1111018 1653217 2712689 2712691
UNII
RG277LF5B3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zelvysia (source: ndc)
Generic Name sapropterin dihydrochloride (source: ndc)
Application Number ANDA218645 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1)
source: ndc

Packages (1)

73289-0070-2 30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1)

Ingredients (1)

sapropterin dihydrochloride (100 mg/1)

Linked Drug Pages (1)

ZELVYSIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34007201-2d47-96fd-e063-6394a90a6327", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "1653217", "2712689", "2712691"], "spl_set_id": ["8de84882-dd24-46f2-8416-5e492d4275d1"], "manufacturer_name": ["Aucta Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (73289-0070-2)  / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1)", "package_ndc": "73289-0070-2", "marketing_start_date": "20250429"}], "brand_name": "ZELVYSIA", "product_id": "73289-0070_34007201-2d47-96fd-e063-6394a90a6327", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Phenylalanine Hydroxylase Activator [EPC]", "Phenylalanine Hydroxylase Activators [MoA]"], "product_ndc": "73289-0070", "generic_name": "SAPROPTERIN DIHYDROCHLORIDE", "labeler_name": "Aucta Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZELVYSIA", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA218645", "marketing_category": "ANDA", "marketing_start_date": "20250429", "listing_expiration_date": "20261231"}