Kalbitor

UNIISPLATC B06AC03

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeB06AC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4778310101
3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

5Q6TZN2HNM

ECALLANTIDE

RxCUI 658708

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5Q6TZN2HNM",
    "rxcui": "658708",
    "inchikey": null,
    "display_name": "ECALLANTIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "f56aec67-c662-477c-b866-bfc23e8809cf": {
      "match": "brand_token",
      "title": "KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "19",
      "published_date": "2025-07-03"
    }
  },
  "productid": "47783-101_1992039f-246f-4057-899b-987d45df152f",
  "productndc": "47783-101",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ECALLANTIDE",
  "proprietary_name": "Kalbitor",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125277",
  "marketing_category": "BLA",
  "nonproprietary_name": "Ecallantide",
  "start_marketing_date": "20100202",
  "active_numerator_strength": "10"
}

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