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United States · US · US:70114-130_7a30003f-a148-4c35-bf21-b4822e970eb5

UDENYCA

UNIISPLATC L03AA13

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

Identification

ManufacturerCoherus Oncology, Inc.
CountryUS (United States)
ATC codeL03AA13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7011413001
    1 SYRINGE in 1 CARTON (70114-130-01) / .6 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
3A58010674
PEGFILGRASTIM
RxCUI 338036
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3A58010674",
    "rxcui": "338036",
    "inchikey": null,
    "display_name": "PEGFILGRASTIM",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "77a8576f-b91e-42ce-b613-2fa3c3d4a571": {
      "match": "brand_token",
      "title": "UDENYCA (PEGFILGRASTIM-CBQV) INJECTION, SOLUTION [ACCORD BIOPHARMA, INC.]",
      "spl_version": "4",
      "published_date": "2026-04-27"
    }
  },
  "productid": "70114-130_7a30003f-a148-4c35-bf21-b4822e970eb5",
  "productndc": "70114-130",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEGFILGRASTIM",
  "proprietary_name": "UDENYCA",
  "active_ingred_unit": "mg/.6mL",
  "application_number": "BLA761039",
  "marketing_category": "BLA",
  "nonproprietary_name": "pegfilgrastim-cbqv",
  "start_marketing_date": "20231222",
  "active_numerator_strength": "6"
}

Related drugs

Other records sharing ATC code L03AA13.

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