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 24 of 158 · 3,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WhiskCare 371ALCOHOLWhisk Products, Inc.bc505f53-2cc9-4cd1-8b34-8d0be4e32aea2026-06-10WarningsExact identifier
unii: 3K9958V90M
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 70WT22SF4B
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d5058d-861a-9e20-e063-6294a90a164c2026-06-09WarningsExact identifier
unii: 70WT22SF4B
B-Pure Moisturizing Hand Sanitizer Alpine Chalet ScentedALCOHOLFourstar Group USA, Inc.03e83cf4-ac40-4208-943a-380a87bbf2a12026-06-09WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Polar Berry ScentedALCOHOLFourstar Group USA, Inc.d1fa6ca0-ba85-4bb7-a7ae-b9ac0c39ea352026-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53dd3d76-81c9-ed6b-e063-6394a90aaea32026-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de29d2-ebf1-7193-e063-6294a90ab3832026-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de8eef-b344-3e25-e063-6394a90a01d82026-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitize Caramel LatteALCOHOLShenzhen Lantern Scicence Co.,Ltd.53df1a36-9b0a-4696-e063-6394a90a91a42026-06-09WarningsExact identifier
unii: 3K9958V90M
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BM Nat PhosNATRUM PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53bacdaf-d7c8-9ae9-e063-6294a90a898c2026-06-08WarningsExact identifier
unii: 70WT22SF4B
MISTIFY COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006e7bf-96f6-1faa-e063-6394a90ab5a32026-06-08WarningsExact identifier
unii: 3K9958V90M
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: 70WT22SF4B
Walgreens VANILLA Hand Sanitizer MistETHYL ALCOHOLWalgreen Company7c083331-3d5f-4248-8b2c-3e7e1b266a792026-06-05WarningsExact identifier
unii: 3K9958V90M
Signature Series Enriched Foam Alcohol Hand SanitizerALCOHOLCintas3633620e-5057-469c-91a5-c628d1c90aca2026-06-05WarningsExact identifier
unii: 3K9958V90M
VANILLA SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limited67c2cb48-481d-41aa-a11d-e00d81d7a34a2026-06-05WarningsExact identifier
unii: 3K9958V90M
TC Enriched Foam Alcohol Hand SanitizerALCOHOLRubbermaid Commercial Products LLC4f3f0d3f-39c6-4ad4-9cb0-6e0d7b568e512026-06-04WarningsExact identifier
unii: 3K9958V90M
BM Nat Phos Icing SugarNATRUM PHOSPHORICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356e3a2-11f9-98e5-e063-6294a90a08eb2026-06-03WarningsExact identifier
unii: 70WT22SF4B
STRAWBERRY SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limited8c9ddf82-fcc8-4575-8a3a-ce11542c3ab42026-06-03WarningsExact identifier
unii: 3K9958V90M
WATERMELON SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limitedf49efe3b-5ad7-4658-a1a7-1e46f48d17842026-06-03WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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