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United States · US · US:68516-5216_185395b1-8739-4a37-8d2a-719bdd12bb3e

ALBUTEIN

UNIISPLATC B05AA01

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

Identification

ManufacturerGRIFOLS USA, LLC
CountryUS (United States)
ATC codeB05AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6851652161
    1 VIAL in 1 CARTON (68516-5216-1) / 50 mL in 1 VIAL (68516-5216-3)
  • ndc11
    6851652162
    1 VIAL in 1 CARTON (68516-5216-2) / 100 mL in 1 VIAL (68516-5216-4)
  • ndc11
    6851652165
    1 VIAL in 1 CARTON (68516-5216-5) / 20 mL in 1 VIAL (68516-5216-6)

Annotations

UNII (FDA Substance ID)
ZIF514RVZR
ALBUMIN HUMAN
RxCUI 828529
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ZIF514RVZR",
    "rxcui": "828529",
    "inchikey": null,
    "display_name": "ALBUMIN HUMAN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e4304edc-8c80-4118-9d86-7a34c76aa56f": {
      "match": "brand_token",
      "title": "ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]",
      "spl_version": "3",
      "published_date": "2025-06-13"
    }
  },
  "productid": "68516-5216_185395b1-8739-4a37-8d2a-719bdd12bb3e",
  "productndc": "68516-5216",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "ALBUMIN HUMAN",
  "proprietary_name": "ALBUTEIN",
  "active_ingred_unit": "g/50mL",
  "application_number": "BLA102478",
  "marketing_category": "BLA",
  "nonproprietary_name": "ALBUMIN (HUMAN)",
  "start_marketing_date": "20220301",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code B05AA01.

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