RECOMBINATE

SPL

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0944284510
1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "d99348b1-edad-41de-aed9-903a6f9f279f": {
      "match": "brand_token",
      "title": "RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "21",
      "published_date": "2025-04-28"
    }
  },
  "productid": "0944-2845_217500ff-5413-48b5-adab-ac72eb2dc128",
  "productndc": "0944-2845",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "RECOMBINATE",
  "active_ingred_unit": null,
  "application_number": "BLA103375",
  "marketing_category": "BLA",
  "nonproprietary_name": "antihemophilic factor recombinant",
  "start_marketing_date": "20100315",
  "active_numerator_strength": null
}

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