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 70 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen, Pink Kiwi Splash ScentedALCOHOLFourstar Group USA, Inc.f8b8b820-467b-49eb-8bec-16d39ba32e962025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid, Berries and Cream ScentedALCOHOLFourstar Group USA, Inc.9b646c4e-69e7-44c2-afa3-8267c25e62022025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.08d9499c-486c-464b-9d81-ba325b95482e2025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Palm Sugar Pineapple ScentedALCOHOLFourstar Group USA, Inc.34d065a1-c5f0-4ba0-8c1b-717049dcb83a2025-12-04WarningsExact identifier
unii: 3K9958V90M
FoamFresh Alco-Foam Hand SanitizerALCOHOLWoodbine Products Company2e9c752c-ad69-4692-a17a-e98b84c7e9a52025-12-04WarningsExact identifier
unii: 3K9958V90M
Mrs. Meyers Clean Day Hand Sanitizer Lavender ScentALCOHOLThe Caldrea Companyd60a985b-6b42-44ea-b48e-81556e4f609a2025-12-04WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
unii: 3K9958V90M
Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHumco Holding Group, Inc.41c0927e-df40-4f83-8fd4-284ec0c02b602025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.451752d3-88bc-9a26-e063-6294a90a288a2025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.45179a84-fa3c-5634-e063-6294a90a0eee2025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.451711f3-3b22-5d39-e063-6294a90a78942025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.4518038c-04ac-0fbe-e063-6294a90a7c322025-12-03WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd44f609dd-c864-493f-e063-6294a90a71382025-12-02WarningsExact identifier
unii: 3K9958V90M
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: 70WT22SF4B
BM Nat PhosNATRUM PHOSPHORICUMBM Private Limited37b0db27-eede-9141-e063-6294a90a8a0c2025-12-02WarningsExact identifier
unii: 70WT22SF4B
BM Nat Phos Icing SugarNATRUM PHOSPHORICUM ICING SUGARBM Private Limited37c22e9a-375d-9018-e063-6294a90a2f562025-12-02WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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