Sephience

Orange BookUNIISPLATC A16AX

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

Identification

ManufacturerPTC Therapeutics Inc.

CountryUS (United States)

ATC codeA16AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5285630103
30 PACKET in 1 CARTON (52856-301-03) / 1 POWDER in 1 PACKET (52856-301-01)

Annotations

UNII (FDA Substance ID)

CJQ26KO7HP

SEPIAPTERIN

Orange Book

N219666

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "CJQ26KO7HP",
    "rxcui": null,
    "inchikey": "VPVOXUSPXFPWBN-VKHMYHEASA-N",
    "display_name": "SEPIAPTERIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "32ac719c-49f0-4105-9c46-18c19583a5c2": {
      "match": "brand_token",
      "title": "SEPHIENCE (SEPIAPTERIN) POWDER [PTC THERAPEUTICS INC.]",
      "spl_version": "6",
      "published_date": "2026-04-28"
    }
  },
  "productid": "52856-301_15baff9a-9d66-4546-b209-7a570a2f16c5",
  "productndc": "52856-301",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "219666",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "250MG/PACKET",
        "product_no": "001",
        "approval_date": "Jul 28, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/PACKET",
        "product_no": "002",
        "approval_date": "Jul 28, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEPIAPTERIN",
  "proprietary_name": "Sephience",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219666",
  "marketing_category": "NDA",
  "nonproprietary_name": "sepiapterin",
  "start_marketing_date": "20250728",
  "active_numerator_strength": "1000"
}

Related drugs

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