Back to search
🇺🇸

United States · US · US:68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc

Gattex

Orange BookUNIISPLATC A16AX08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA16AX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6887501012
    30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1)

Annotations

UNII (FDA Substance ID)
7M19191IKG
TEDUGLUTIDE
RxCUI 1364468
Orange Book
N203441
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7M19191IKG",
    "rxcui": "1364468",
    "inchikey": null,
    "display_name": "TEDUGLUTIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "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": "68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc",
  "productndc": "68875-0101",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "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": "TEDUGLUTIDE",
  "proprietary_name": "Gattex",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA203441",
  "marketing_category": "NDA",
  "nonproprietary_name": "teduglutide",
  "start_marketing_date": "20121221",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code A16AX08.

Access this data programmatically

Query Gattex and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.