gattex

Generic: teduglutide

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gattex
Generic Name teduglutide
Labeler takeda pharmaceuticals america, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

teduglutide 5 mg/.5mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 68875-0101
Product ID 68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203441
Listing Expiration 2026-12-31
Marketing Start 2012-12-21

Pharmacologic Class

Established (EPC)
glp-2 analog [epc]
Mechanism of Action
glucagon-like peptide-2 (glp-2) agonists [moa]
Chemical Structure
glucagon-like peptide 2 [chemical/ingredient] analogs/derivatives [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 688750101
Hyphenated Format 68875-0101

Supplemental Identifiers

RxCUI
1364472 1364477 1489307
UNII
7M19191IKG
NUI
N0000190992 N0000190990 N0000175140 N0000175452

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gattex (source: ndc)
Generic Name teduglutide (source: ndc)
Application Number NDA203441 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/.5mL
source: ndc
Packaging
  • 30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1)
source: ndc

Packages (1)

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

Ingredients (1)

teduglutide (5 mg/.5mL)

Linked Drug Pages (1)

Gattex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "20ca0019-d3a4-4a8f-8dd4-67179d06e4dc", "openfda": {"nui": ["N0000190992", "N0000190990", "N0000175140", "N0000175452"], "unii": ["7M19191IKG"], "rxcui": ["1364472", "1364477", "1489307"], "spl_set_id": ["66b69c1e-b25c-44d3-b5ff-1c1de9a516fa"], "pharm_class_cs": ["Glucagon-Like Peptide 2 [Chemical/Ingredient]", "Analogs/Derivatives [Chemical/Ingredient]"], "pharm_class_epc": ["GLP-2 Analog [EPC]"], "pharm_class_moa": ["Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL in 1 CARTON (68875-0101-2)  / .5 mL in 1 VIAL (68875-0101-1)", "package_ndc": "68875-0101-2", "marketing_start_date": "20121221"}], "brand_name": "Gattex", "product_id": "68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "GLP-2 Analog [EPC]", "Glucagon-Like Peptide 2 [Chemical/Ingredient]", "Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]"], "product_ndc": "68875-0101", "generic_name": "teduglutide", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gattex", "active_ingredients": [{"name": "TEDUGLUTIDE", "strength": "5 mg/.5mL"}], "application_number": "NDA203441", "marketing_category": "NDA", "marketing_start_date": "20121221", "listing_expiration_date": "20261231"}