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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
- ndc11688750101230 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.
- DKNilletoAdAlvo Limited
- PLRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- ISRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- FIRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- DKRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- DKRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- ISRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- PLRevestiveTakeda Pharmaceuticals International AG Ireland Branch
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