KEPIVANCE

UNIISPLATC V03AF08

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

Identification

ManufacturerSwedish Orphan Biovitrum AB (publ)

CountryUS (United States)

ATC codeV03AF08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6665811303
3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)

Annotations

UNII (FDA Substance ID)

QMS40680K6

PALIFERMIN

RxCUI 196319

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QMS40680K6",
    "rxcui": "196319",
    "inchikey": null,
    "display_name": "PALIFERMIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "426f6e64-2c20-4a61-6d65-7320426f6e64": {
      "match": "brand_token",
      "title": "KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]",
      "spl_version": "22",
      "published_date": "2025-12-19"
    }
  },
  "productid": "66658-113_462812de-e664-609f-e063-6294a90a1e3d",
  "productndc": "66658-113",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALIFERMIN",
  "proprietary_name": "KEPIVANCE",
  "active_ingred_unit": "mg/1.2mL",
  "application_number": "BLA125103",
  "marketing_category": "BLA",
  "nonproprietary_name": "palifermin",
  "start_marketing_date": "20230804",
  "active_numerator_strength": "5.16"
}

Related drugs

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