Kuvan

Orange BookUNIISPLATC A16AX07

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

Identification

ManufacturerBioMarin Pharmaceutical Inc.

CountryUS (United States)

ATC codeA16AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6813530122
30 PACKET in 1 CARTON (68135-301-22) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11)

Annotations

UNII (FDA Substance ID)

RG277LF5B3

SAPROPTERIN DIHYDROCHLORIDE

RxCUI 753341

Orange Book

N205065

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": {
    "af38711e-8873-4790-a92d-4d583e23fb89": {
      "match": "brand_token",
      "title": "KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]",
      "spl_version": "79",
      "published_date": "2025-11-26"
    }
  },
  "productid": "68135-301_c4286a54-6e01-4444-94a0-943411790e1d",
  "productndc": "68135-301",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "205065",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG/PACKET",
        "product_no": "001",
        "approval_date": "Dec 19, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG/PACKET",
        "product_no": "002",
        "approval_date": "Oct 27, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SAPROPTERIN DIHYDROCHLORIDE",
  "proprietary_name": "Kuvan",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205065",
  "marketing_category": "NDA",
  "nonproprietary_name": "SAPROPTERIN DIHYDROCHLORIDE",
  "start_marketing_date": "20140221",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code A16AX07.

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