Home NDC 68875-0102-01 NDC 68875-0102-01 - Gattex This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 68875-0102
Requested NDC 68875-0102-01
Package NDCs from labels 68875-0102-1, 68875-0102-01
Manufacturer Takeda Pharmaceuticals America, Inc.
Effective date 2025-09-05
Current FDA listing Not matched in FDA.report NDC product tables FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68875-0101-1 Gattex 0.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 15 mL 5 mg in 0.5mL 20 68875-0102-1 Gattex 1 in 1 CARTON KIT 1 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68875-0102 GATTEX (TEDUGLUTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20241003_66b69c1e-b25c-44d3-b5ff-1c1de9a516fa.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded teduglutide ACTIVE INGREDIENT 7M19191IKG GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 water ACTIVE INGREDIENT 059QF0KO0R GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 teduglutide ACTIVE MOIETY 7M19191IKG GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 water ACTIVE MOIETY 059QF0KO0R GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 Histidine INACTIVE INGREDIENT 4QD397987E GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 mannitol INACTIVE INGREDIENT 3OWL53L36A GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 sodium phosphate, dibasic, heptahydrate INACTIVE INGREDIENT 70WT22SF4B GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 sodium phosphate, monobasic, monohydrate INACTIVE INGREDIENT 593YOG76RN GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3
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Matched openFDA labels page 12 of 158 · 3,155 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.