FDA.reportPublic FDA data

NDC 68992-3075-01 - 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
68992-3075
Requested NDC
68992-3075-01
Package NDCs from labels
68992-3075-3, 68992-3075-1, 68992-3075-01
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
68992-3075-1EnvarsusXR1 in 1 CARTONTABLET, EXTENDED RELEASE116
68992-3075-1EnvarsusXR1 in 1 POUCHTABLET, EXTENDED RELEASE116
68992-3075-3EnvarsusXR1 in 1 POUCHTABLET, EXTENDED RELEASE116
68992-3075-3EnvarsusXR1 in 1 CARTONTABLET, EXTENDED RELEASE116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68992-3075ENVARSUS 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
68992-3075-1EA - Each68992-30753681cbb4-7b0f-4f39-8f3b-1845a3ef869b12015-10-02
68992-3075-3EA - Each68992-30754ec4185d-6a36-48e0-834a-91acf249493512015-10-02

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 18 of 36 · 715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
unii: 92RU3N3Y1O
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: W4888I119H
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
unii: 92RU3N3Y1O
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd9234e-d1cc-4cce-e053-2991aa0a457e2025-07-09WarningsExact identifier
unii: 92RU3N3Y1O
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEMajor Pharmaceuticals1bc90fa7-fcce-4a9b-862f-f30ab602ecab2025-07-07WarningsExact identifier
unii: 92RU3N3Y1O
Curist Gas ReliefSIMETHICONELittle Pharma. Inc.3948c0e5-4ee7-5443-e063-6294a90ad6ae2025-07-06WarningsExact identifier
unii: 92RU3N3Y1O
TacrolimusTACROLIMUSBryant Ranch Prepack54fcc518-21d9-44a8-9e2c-87ebc2b3e2e62025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WM0HAQ4WNM
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
unii: 92RU3N3Y1O
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONERising Pharma Holdings, Inc.982129d4-3cbf-4793-a861-d6c8f34bedc32025-07-01WarningsExact identifier
unii: 92RU3N3Y1O
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEH E B35cff261-932e-4b2e-ab21-80969c27fa922025-06-27WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 125 mgSIMETHICONEATLANTIC BIOLOGICALS CORP.4ce98db3-c7a6-4627-88c5-9de302a531882025-06-27WarningsExact identifier
unii: 92RU3N3Y1O
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
unii: 92RU3N3Y1O
Silicone Scar CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd37d02d8c-fbb5-5ba5-e063-6294a90a43ac2025-06-17WarningsExact identifier
unii: 92RU3N3Y1O
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
TacrolimusTACROLIMUSAccord Healthcare Inc.bd447ffa-9196-4c3c-accf-5adf29b846652025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WM0HAQ4WNM
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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