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 114 of 156 · 3,116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
unii: 3K9958V90M
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLNatures Formulae Health Products Ltd.a7da75b3-b55d-641c-e053-2995a90a43b72024-12-17WarningsExact identifier
unii: 3K9958V90M
Foster and Thrive Decolorized IodineALCOHOL LIQUIDStrategic Sourcing Services, LLC2981529a-2bd0-3e9e-e063-6294a90a72362024-12-17WarningsExact identifier
unii: 3K9958V90M
PURELL VF PLUS Hand Sanitizer GelALCOHOLGOJO Industries, Inc.788a154e-f32f-410f-8648-f0bbd0772e662024-12-16WarningsExact identifier
unii: 3K9958V90M
SAN X E3ALCOHOLAmerisan, LLCd6e219a6-f4d6-b8df-e053-2995a90a58032024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Moisturizing 2in1 FoamALCOHOLGOJO Industries, Inc.19d4a358-74e0-4333-ace9-ed8b4ce729992024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.333246ca-9420-44c9-9240-37a9cdc03e2b2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Naturals FoamALCOHOLGOJO Industries, Inc.0b881323-938b-405f-beb2-0875256d37222024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer PRIME DEFENSEALCOHOLGOJO Industries, Inc.9962349e-ed78-4b22-be00-e38ab0c55dfe2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Lavender and VerbenaALCOHOLGOJO Industries, Inc.6a17d905-a55e-413c-b2af-0b06bf0d35c32024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP UnscentedALCOHOLGOJO Industries, Inc.f87058df-2efd-4ea8-ae37-35e472bd091f2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Tangerine and PearALCOHOLGOJO Industries, Inc.92df06a9-826b-493c-b865-295b8e9acb142024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Waterless Surgical ScrubALCOHOLGOJO Industries, Inc.e3ed5e0c-1e21-47eb-a999-9c8aa5083dff2024-12-16WarningsExact identifier
unii: 3K9958V90M
Soft Care Impact Alcohol Instant Hand SanitizerALCOHOLDiversey, Inc.938d5a47-f18f-4bae-bd65-4fc98985e4282024-12-16WarningsExact identifier
unii: 3K9958V90M
Soft Care Foam Instant Hand SanitizerALCOHOLDiversey, Inc.674e63ec-445b-4b7a-af15-63d9d624cf1a2024-12-16WarningsExact identifier
unii: 3K9958V90M
Soft Care Impact Foam Alcohol Foam Instant Hand SanitizerALCOHOLDiversey, Inc.3b06c40c-9f15-4bc5-ad9b-053f4c4fc1b52024-12-16WarningsExact identifier
unii: 3K9958V90M
Soft Care Hand Sanitizing WipesALCOHOLDiversey, Inc.97cd7474-05d7-30b8-e053-2995a90adf772024-12-16WarningsExact identifier
rxcui: 1489307
unii: 3K9958V90M
Smart-San Hand Sanitizer FoamALCOHOLBest Sanitizers, Inc.291a53ff-b726-1acf-e063-6294a90a0aab2024-12-13WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sparkling LimoncelloALCOHOLBath & Body Works, Inc.292866b1-230b-771f-e063-6294a90ac3ef2024-12-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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