Gammaplex

UNIISPL

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

Identification

ManufacturerBio Products Laboratory Ltd

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6420882355
1 BOTTLE, GLASS in 1 CARTON (64208-8235-5) / 50 mL in 1 BOTTLE, GLASS (64208-8235-1)
ndc11
6420882356
1 BOTTLE, GLASS in 1 CARTON (64208-8235-6) / 100 mL in 1 BOTTLE, GLASS (64208-8235-2)
ndc11
6420882357
1 BOTTLE, GLASS in 1 CARTON (64208-8235-7) / 200 mL in 1 BOTTLE, GLASS (64208-8235-3)

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": {
    "2098af41-aec7-4af7-98bb-54f8ab55f30e": {
      "match": "brand_token",
      "title": "GAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LTD]",
      "spl_version": "16",
      "published_date": "2025-11-17"
    }
  },
  "productid": "64208-8235_a1aa7eb5-47eb-4da5-b8ad-d32b52594a2e",
  "productndc": "64208-8235",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "Gammaplex",
  "active_ingred_unit": "g/50mL",
  "application_number": "BLA125329",
  "marketing_category": "BLA",
  "nonproprietary_name": "HUMAN IMMUNOGLOBULIN G",
  "start_marketing_date": "20170407",
  "active_numerator_strength": "5"
}

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