UDENYCA

UNIISPLATC L03AA13

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

Identification

ManufacturerAccord BioPharma, Inc.

CountryUS (United States)

ATC codeL03AA13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6944802763
1 SYRINGE in 1 CARTON (69448-027-63) / .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": "69448-027_b9326155-8307-4ac1-9c13-6598e6c7a361",
  "productndc": "69448-027",
  "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": "20251027",
  "active_numerator_strength": "6"
}

Related drugs

Other records sharing ATC code L03AA13.

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