BIVIGAM

UNIISPL

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

Identification

ManufacturerADMA Biologics, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6980065021
1 VIAL, SINGLE-USE in 1 CARTON (69800-6502-1) / 50 mL in 1 VIAL, SINGLE-USE (69800-6502-2)

Annotations

UNII (FDA Substance ID)

66Y330CJHS

HUMAN IMMUNOGLOBULIN G

RxCUI 1426680

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "66Y330CJHS",
    "rxcui": "1426680",
    "inchikey": null,
    "display_name": "HUMAN IMMUNOGLOBULIN G",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a2244aa0-a6d0-11df-b385-0002a5d5c51b": {
      "match": "brand_token",
      "title": "BIVIGAM (IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%) INJECTION, SOLUTION [ADMA BIOLOGICS, INC.]",
      "spl_version": "15",
      "published_date": "2025-05-07"
    }
  },
  "productid": "69800-6502_3469d327-8d5d-fff5-e063-6394a90a2cf2",
  "productndc": "69800-6502",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "BIVIGAM",
  "active_ingred_unit": "g/50mL",
  "application_number": "BLA125389",
  "marketing_category": "BLA",
  "nonproprietary_name": "Immune Globulin Intravenous (Human) 10%",
  "start_marketing_date": "20130121",
  "active_numerator_strength": "5"
}

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