FDA.reportPublic FDA data

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

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gattex - Takeda Pharmaceuticals America, Inc.Takeda Pharmaceuticals America, Inc.2025-09-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68875-0102-12021-02-11C16284748780-1ba0f9c33-1dc3-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX. GATTEX ® (teduglutide) for injection, for subcutaneous use Initial U.S. Approval: 2012
68875-0102-12021-01-29C16284748780-1ba0f9c33-1dc3-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX. GATTEX ® (teduglutide) for injection, for subcutaneous use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68875-0101-1Gattex0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,15 mL5 mg in 0.5mL20
68875-0102-1Gattex1 in 1 CARTONKIT120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68875-0102GATTEX (TEDUGLUTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]19Current NDC, Legacy NDC, 2 package rows20241003_66b69c1e-b25c-44d3-b5ff-1c1de9a516fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68875-0102-1EA - Each68875-010234eaa60b-4e73-4c0e-a8d7-f995335386f712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
teduglutideACTIVE INGREDIENT7M19191IKGGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
waterACTIVE INGREDIENT059QF0KO0RGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
teduglutideACTIVE MOIETY7M19191IKGGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
waterACTIVE MOIETY059QF0KO0RGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
HistidineINACTIVE INGREDIENT4QD397987EGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
mannitolINACTIVE INGREDIENT3OWL53L36AGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
sodium phosphate, dibasic, heptahydrateINACTIVE INGREDIENT70WT22SF4BGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNGATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 73 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surface x Cutie Pals Hand Sanitizer Cherry ColaALCOHOLI World LLC4420574a-bc9b-a5aa-e063-6394a90a577f2025-11-21WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer lavender aloeETHYL ALCOHOLEO Products, LLCecfcf690-5ce8-4827-b13e-f09fd04a046b2025-11-21WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes ruby grapefruitETHYL ALCOHOLEO Products, LLC35a95320-10c9-403c-81d3-17b47954e3a92025-11-21WarningsExact identifier
unii: 3K9958V90M
EO HAND SANITIZER LavenderALCOHOLEO Products, LLC36b26803-ed48-498f-bc0e-15473495a35a2025-11-21WarningsExact identifier
unii: 3K9958V90M
Smart Care JASMINE GARDENIA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6fef7c0b-04f8-4c26-95fa-79911d875e182025-11-21WarningsExact identifier
unii: 3K9958V90M
EO HAND SANITIZER LavenderALCOHOLEO Products, LLC4192e27f-0034-4cd9-b9e0-27b52cb4b9702025-11-21WarningsExact identifier
unii: 3K9958V90M
Candida HPBAPTISIA TINCTORIA ROOT, ECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, ASTRAGALUS NUTTALLII LEAF, CANDIDA ALBICANS, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NITRIC ACIDNatural Creations, Inc.b587a3f0-628b-41f7-8afb-2cdcd896279e2025-11-20WarningsExact identifier
unii: 70WT22SF4B
EO HAND SANITIZER UnscentedALCOHOLEO Products, LLC7c2bf597-65f1-44ad-9cfd-05cd7e9973c82025-11-20WarningsExact identifier
unii: 3K9958V90M
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Lavender Hand Sanitizing WipesETHANOLWhole Foods Market, Inc.039edd3c-8ccd-0c6c-e063-6294a90ab9ba2025-11-20WarningsExact identifier
unii: 3K9958V90M
Lavender Hand Sanitizer WipesETHANOLWhole Foods Market, Inc.039dfc12-6088-1b1f-e063-6394a90a7e922025-11-20WarningsExact identifier
unii: 3K9958V90M
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
unii: 3K9958V90M
Plus Brasept Alcocol GelALCOHOLNEWDROP NORTH AMERICA LLCf791c99c-5879-9ba2-e053-6394a90ad3c72025-11-20WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
unii: 3K9958V90M
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
unii: 70WT22SF4B
INSTANT HAND SANITIZER ClassicETHYL ALCOHOLUniversal Distribution Center LLC65faf3d6-4e1c-4092-ac77-f6d77bf49cd62025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer coconut lemonETHYL ALCOHOLEO Products, LLCe42fae4c-4e6e-4309-b6fa-2fbb95c5cbc22025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes lavender aloeETHYL ALCOHOLEO Products, LLC8128b366-c2e3-4ffc-948f-299227a364a12025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes coconut lemonETHYL ALCOHOLEO Products, LLC809049d8-a71e-44e1-986e-0473ee0fb6702025-11-19WarningsExact identifier
unii: 3K9958V90M
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.