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United States · US · US:61314-318_5047f866-a689-466d-9808-52138bd638c4

ZARXIO

UNIISPLATC L03AA02

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

Identification

ManufacturerSandoz Inc.
CountryUS (United States)
ATC codeL03AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6131431801
    1 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
  • ndc11
    6131431810
    2 BLISTER PACK in 1 CARTON (61314-318-10) / 5 SYRINGE in 1 BLISTER PACK (61314-318-05) / .5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
PVI5M0M1GW
FILGRASTIM
RxCUI 68442
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "PVI5M0M1GW",
    "rxcui": "68442",
    "inchikey": null,
    "display_name": "FILGRASTIM",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "c0d1c22b-566b-4776-bdbf-00f96dad0cae": {
      "match": "brand_token",
      "title": "ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC.]",
      "spl_version": "13",
      "published_date": "2025-11-17"
    }
  },
  "productid": "61314-318_5047f866-a689-466d-9808-52138bd638c4",
  "productndc": "61314-318",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FILGRASTIM",
  "proprietary_name": "ZARXIO",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "BLA125553",
  "marketing_category": "BLA",
  "nonproprietary_name": "filgrastim-sndz",
  "start_marketing_date": "20150306",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code L03AA02.

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