FDA.reportPublic FDA data

NDC 68992-3040-01 - Envarsus XR

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
68992-3040
Requested NDC
68992-3040-01
Package NDCs from labels
68992-3040-3, 68992-3040-1, 68992-3040-01
Manufacturer
Veloxis Pharmaceuticals, Inc | Rottendorf Pharma GmbH | Pharma Packaging Solutions, LLC dba Tjoapack, LLC
Effective date
2025-02-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Envarsus XRVeloxis Pharmaceuticals, Inc | Rottendorf Pharma GmbH | Pharma Packaging Solutions, LLC dba Tjoapack, LLC2025-02-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68992-3040-1EnvarsusXR1 in 1 POUCHTABLET, EXTENDED RELEASE116
68992-3040-1EnvarsusXR1 in 1 CARTONTABLET, EXTENDED RELEASE116
68992-3040-3EnvarsusXR1 in 1 CARTONTABLET, EXTENDED RELEASE116
68992-3040-3EnvarsusXR1 in 1 POUCHTABLET, EXTENDED RELEASE116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68992-3040ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]16Current NDC, Legacy NDC, 4 package rows20250302_de2315b0-6344-43ac-9aea-3e3b68d828e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68992-3040-1EA - Each68992-30408a9a3060-891a-494c-a738-d8fea61368d812015-10-02
68992-3040-3EA - Each68992-30408a01cf3e-c6af-482c-ac4d-a6a5849e648c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]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 19 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
unii: 92RU3N3Y1O
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6223134-8a2e-d1ec-e053-2995a90a90772025-04-28WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCAR CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd338180f7-2449-3d13-e063-6294a90a90832025-04-24WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb2025-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 125 MGNUVICARE LLC5c6352b9-fd8a-4876-b089-e4c1d15cd2642025-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief - Cherry FlavorSIMETHICONETARGET CORPORATION290fe08d-a0b9-82f7-e063-6394a90a9c752025-04-11WarningsExact identifier
unii: 92RU3N3Y1O
InfantsSIMETHICONEATLANTIC BIOLOGICALS CORP.27fce442-e328-41d2-bab9-87ab21550c042025-04-11WarningsExact identifier
unii: 92RU3N3Y1O
Rolaids Advanced Antacid Anti-gas Mixed BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.3884c05a-a593-424e-88b3-be962e73488e2025-04-10WarningsExact identifier
unii: 92RU3N3Y1O
good neighbor pharmacy anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerisource Bergen5dae1247-3ec0-495e-b3f2-1c15551416172025-04-08WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFSA store INC0199a50f-f367-40e7-8af0-745a959d3fde2025-04-05WarningsExact identifier
unii: 92RU3N3Y1O
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
unii: 92RU3N3Y1O
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Max Gas Antacid plus Anti-Gas ChewsSIMETHICONETopCo309e8215-84b0-dd84-e063-6394a90ac4422025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Cherry Berry Lime Antacid HBGCALCIUM CARBONATETopCo30a01bf6-28c8-87ae-e063-6394a90a6fb52025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra Strength SoftgelsSIMETHICONEHaleon US Holdings LLCfa4a3b07-591b-4445-aa67-b17ba1e67d5c2025-03-14WarningsExact identifier
unii: 92RU3N3Y1O
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDiscount Drug Mart, Inc2e0b3aec-f436-c0fb-e063-6394a90abb512025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
unii: 92RU3N3Y1O
Envarsus XRTACROLIMUSVeloxis Pharmaceuticals, Incde2315b0-6344-43ac-9aea-3e3b68d828e72025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA206406
ndc (package): 68992-3040-1
ndc (package): 68992-3040-3
ndc (package): 68992-3010-1
ndc (package): 68992-3075-1
ndc (package): 68992-3010-3
ndc (package): 68992-3075-3
ndc (product): 68992-3040
ndc (product): 68992-3075
ndc (product): 68992-3010
ndc11 (package): 68992304001
rxcui: 1664440
rxcui: 1664461
rxcui: 1664463
rxcui: 1664456
rxcui: 1664434
rxcui: 1664458
spl id: 163c129d-f4e2-484d-af96-c265c9a5e38c
spl set id: de2315b0-6344-43ac-9aea-3e3b68d828e7
unii: WM0HAQ4WNM
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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