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 50 of 158 · 3,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLThe Kroger Co.9f95d956-25db-4ffa-86cc-a160677124b82026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLThe Kroger Co.a848de11-0438-400b-b363-df595692685a2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLThe Kroger Co.163b479b-aa0f-4174-8dfb-ac33bd07752a2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Ethyl alcoholETHYL ALCOHOLWalmart Inc.f7d9bb83-0b80-458b-9554-8adbe51473e42026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLWalmart Inc.2112ba04-1584-46dd-9a7b-2dfd27e501b72026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLWalmart Inc.c05bcb17-f1f6-4e3a-b90a-5d003ce5215b2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Dial Professional Gel SanitizerDIAL PROFESSIONAL GEL HAND SANITIZERHenkel Corporation2862ab27-b5e7-8bdb-e063-6394a90abf802026-02-27WarningsExact identifier
unii: 3K9958V90M
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION HAND SANITIZER WILD Cherry SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOdc344dee-1a46-49cb-bead-227f64bc04ea2026-02-27WarningsExact identifier
unii: 3K9958V90M
RubbingETHYL ALCOHOLUnited Natural Foods, Inc. dba UNFIcd03611f-879a-4888-8d45-f8bdfd82529c2026-02-26Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Avant Original - Fragrance FreeALCOHOLB4 Soap LLC35a2d0ba-9209-4d70-b3b4-537225f83c842026-02-26WarningsExact identifier
unii: 3K9958V90M
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 70WT22SF4B
Advanced Hand Sanitizer with AloeADVANCED HAND SANITIZER WITH ALOEChain Drug Marketing Association4977f769-7dc9-be56-e063-6394a90a852c2026-02-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerADVANCED HAND SANITIZERChain Drug Marketing Association49a1001c-8f4e-d0e7-e063-6394a90a53062026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLChain Drug Marketing Associationa85d93f2-e6f0-4fad-9ff7-6cbb62942bb22026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AdvancedETHYL ALCOHOLPerrigo Direct, Inc68eca241-acce-4f12-9643-bec9b14f53d02026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLMeijer, Inc.a56b4a66-3923-4e40-a461-1d97043fb89a2026-02-19Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Eucalyptus and SpearmintALCOHOLBath & Body Works, Inc.38d5ca92-2518-3dc4-e063-6394a90a2bc02026-02-19WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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