ZELVYSIA

Orange BookUNIISPLATC A16AX07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAucta Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA16AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7328900712
30 PACKET in 1 CARTON (73289-0071-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1)

Annotations

UNII (FDA Substance ID)

RG277LF5B3

SAPROPTERIN DIHYDROCHLORIDE

RxCUI 753341

Orange Book

A218645

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RG277LF5B3",
    "rxcui": "753341",
    "inchikey": "RKSUYBCOVNCALL-NTVURLEBSA-N",
    "display_name": "SAPROPTERIN DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8de84882-dd24-46f2-8416-5e492d4275d1": {
      "match": "brand_token",
      "title": "ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [AUCTA PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2025-05-02"
    }
  },
  "productid": "73289-0071_34007201-2d47-96fd-e063-6394a90a6327",
  "productndc": "73289-0071",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "218645",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG/PACKET",
        "product_no": "001",
        "approval_date": "Apr 29, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG/PACKET",
        "product_no": "002",
        "approval_date": "Apr 29, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SAPROPTERIN DIHYDROCHLORIDE",
  "proprietary_name": "ZELVYSIA",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218645",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sapropterin dihydrochloride",
  "start_marketing_date": "20250429",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A16AX07.

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