Gattex

Orange BookSPL

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
6887501031
1 KIT in 1 CARTON (68875-0103-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1)

Annotations

Orange Book

N203441

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "66b69c1e-b25c-44d3-b5ff-1c1de9a516fa": {
      "match": "brand_token",
      "title": "GATTEX (TEDUGLUTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "20",
      "published_date": "2025-09-18"
    }
  },
  "productid": "68875-0103_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc",
  "productndc": "68875-0103",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203441",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 21, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Gattex",
  "active_ingred_unit": null,
  "application_number": "NDA203441",
  "marketing_category": "NDA",
  "nonproprietary_name": "teduglutide",
  "start_marketing_date": "20121221",
  "active_numerator_strength": null
}

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