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 56 of 158 · 3,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Hand SanitizerETHYL ALCOHOLDemoulas Super Markets, Inc0c84b49c-1473-422e-8d7b-da875c6a2c1a2026-02-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Morning DewALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f60996-6a03-77e0-e063-6394a90a7a112026-02-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Wild Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f64148-5c63-0107-e063-6294a90a0c452026-02-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Incc97eae06-df1f-4f3e-bef3-66882a3898932026-02-02WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFourstar Group USA, Inc26ae8950-a770-4755-aa51-7e3a24cdae842026-02-02WarningsExact identifier
unii: 3K9958V90M
hand sanitizerHAND SANITIZERJINHUA YINKOU COSMETICS CO.,LTD49e26e51-6c32-7986-e063-6394a90a1d232026-02-02WarningsExact identifier
unii: 3K9958V90M
INSTANT HAND SANITIZERINSTANT HAND SANITIZERNINGBO MEITELI COSMETICS CO., LTD49e44671-5d79-aa8e-e063-6294a90a9d2e2026-02-02WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer WHITE JASMINE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2c904dad-b8d9-49c5-9cbf-b5916f05c2c12026-01-31WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLRite Aid Corporationf7eb3c0e-4e53-45d8-88f9-95026f5e3efb2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLRite Aid Corporation5f474ef9-0459-4192-b31d-cbf69c7a2b9a2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
SOUR LEMON Hand Sanitizer MARSHMALLOW SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3ce38e8c-8f57-480b-86be-8bf7681bbb882026-01-30WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAldi, Incaaa55815-ab6d-41c0-b04f-53de8001ebc72026-01-29WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLAmerisource Bergene2718f0e-14e9-4698-8400-f5dfe9169bf72026-01-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Ethyl Rubbing AlcoholETHYL ALCOHOLCardinal Health, 110 dba Leaderc56cbcbf-8e0e-4dff-80d3-df420c500a932026-01-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Adventure Hand Sanitizer - Fragrance 80%ALCOHOLNICETY SOLUTIONS LLCa507c20e-37d8-ea80-e053-2a95a90a41d42026-01-29WarningsExact identifier
unii: 3K9958V90M
Adventure Hand Sanitizer - Unscented 80%ALCOHOLNICETY SOLUTIONS LLCa5077eb2-4adb-0680-e053-2995a90a2cef2026-01-29WarningsExact identifier
unii: 3K9958V90M
ESC Protecting Foam Hand SanitizerALCOHOLEcolab Inc.d0820c4c-b320-4d3d-8ee3-de24fbed227b2026-01-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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