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 96 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care CARAMEL HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.fce4d7d6-d505-482b-971f-7874e8631de72025-05-21WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Cozy ComfortALCOHOLScent Theory Products LLC35965496-d101-c604-e063-6294a90a1a482025-05-20WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Whipped ChaiALCOHOLScent Theory Products LLC35966f42-1f59-e5f5-e063-6294a90a99822025-05-20WarningsExact identifier
unii: 3K9958V90M
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.db649f36-04b9-47f3-a334-94d3247f80de2025-05-16WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand Sanitizer With AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.52dccfd7-c288-469e-a067-ee6e5776fd6b2025-05-16WarningsExact identifier
unii: 3K9958V90M
Signature Care Instant Hand Sanitizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.49a3c389-33e3-4bd7-a3e7-fe5f4f722bdf2025-05-16WarningsExact identifier
rxcui: 1489307
unii: 3K9958V90M
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Smart Care Holiday Hand Sanitizer - Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ebff92-c075-efdb-e063-6394a90a768f2025-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer - CaramelALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ec6817-98e4-2d8c-e063-6394a90ad5df2025-05-12WarningsExact identifier
unii: 3K9958V90M
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsExact identifier
unii: 3K9958V90M
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsExact identifier
unii: 3K9958V90M
meijer VANILLA SUGAR SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.41d754fb-1417-498e-b7a3-55ffb1a9fcb32025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Pumpkin ScentedALCOHOLFOURSTAR GROUP USA, INC.7ea6ec9d-323d-4f81-bc86-94cd0e6cc0142025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.29448472-af23-4ed2-93a9-9d57b7d8d0812025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Ginger Citrus ScentedALCOHOLFOURSTAR GROUP USA, INC.100184a8-6298-4c57-a831-cd5fa55a66b02025-05-07WarningsExact identifier
unii: 3K9958V90M
meijer WATERMELON SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.9dc31149-9ba1-4014-9a51-21e558652ca52025-05-06WarningsExact identifier
unii: 3K9958V90M
meijer BERRY SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.7bbd6459-0cb6-4b48-b842-0d585295ed802025-05-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Mocha Coffee ScentedALCOHOLFOURSTAR GROUP USA, INC.8130954d-ba43-478d-b260-b74eaa2ab3752025-05-05WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Almond Vanilla ScentedALCOHOLFOURSTAR GROUP USA, INC.e9628d75-6271-47f7-8e96-cc06b2496b3b2025-05-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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