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United States · US · US:59353-408_24eb3030-78a2-44cc-b150-c09ec0f080af

Mircera

UNIISPLATC B03XA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerVifor (International) Inc.
CountryUS (United States)
ATC codeB03XA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5935340809
    1 SYRINGE, GLASS in 1 CARTON (59353-408-09) / 1 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
LR3UXN0193
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
RxCUI 729596
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "LR3UXN0193",
    "rxcui": "729596",
    "inchikey": null,
    "display_name": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "22c56f2a-f73c-60e7-e054-00144ff88e88": {
      "match": "brand_token",
      "title": "MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]",
      "spl_version": "9",
      "published_date": "2024-06-17"
    }
  },
  "productid": "59353-408_24eb3030-78a2-44cc-b150-c09ec0f080af",
  "productndc": "59353-408",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA",
  "proprietary_name": "Mircera",
  "active_ingred_unit": "ug/.6mL",
  "application_number": "BLA125164",
  "marketing_category": "BLA",
  "nonproprietary_name": "Methoxy polyethylene glycol-epoetin beta",
  "start_marketing_date": "20141024",
  "active_numerator_strength": "360"
}

Related drugs

Other records sharing ATC code B03XA03.

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