HEPCLUDEX

UNIISPLATC J05AX28

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

Identification

ManufacturerGilead Sciences, Inc.

CountryUS (United States)

ATC codeJ05AX28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6195831041
30 VIAL, SINGLE-DOSE in 1 CARTON (61958-3104-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (61958-3104-2)

Annotations

UNII (FDA Substance ID)

LLM855Y3S3

BULEVIRTIDE ACETATE

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LLM855Y3S3",
    "rxcui": null,
    "inchikey": null,
    "display_name": "BULEVIRTIDE ACETATE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "12391cc2-38c2-4cf5-86d3-2be9370127fc": {
      "match": "brand_token",
      "title": "HEPCLUDEX (BULEVIRTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GILEAD SCIENCES, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-25"
    }
  },
  "productid": "61958-3104_11157b93-ad66-4935-8d4a-b0829c809187",
  "productndc": "61958-3104",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BULEVIRTIDE ACETATE",
  "proprietary_name": "HEPCLUDEX",
  "active_ingred_unit": "mg/1",
  "application_number": "BLA761468",
  "marketing_category": "BLA",
  "nonproprietary_name": "BULEVIRTIDE",
  "start_marketing_date": "20260522",
  "active_numerator_strength": "8.5"
}

Related drugs

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