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 22 of 36 · 715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
extra strength Gas Relief cherry cremeSIMETHICONEAmerisource Bergen1e8e8d85-10e2-1273-e063-6394a90a15582025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
TacrolimusTACROLIMUSBryant Ranch Prepackf21115e2-1d02-4bce-9c13-bf593a52a12f2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WM0HAQ4WNM
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC769e3cc0-6be9-4ab6-88e1-08803d698ef72025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALMART INC.12940c3b-dc58-31fb-e063-6294a90ae8802025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBetter Living Brands, LLCfad9a144-6d1e-be06-e053-6394a90a870c2025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONENORTHEAST PHARMAd106d8e5-cdbb-4f90-8456-e692ffe7f4e62025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFamily Dollar Stores, LLCf86d2c23-c43a-4190-e053-6394a90a95cc2025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALGREEN CO.e22b6c3c-3547-b507-e053-2995a90a714f2025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f2025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
unii: 92RU3N3Y1O
Royal Jelly Scar BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.27be84c1-0227-41ca-beb6-3855eff77e412025-01-02WarningsExact identifier
unii: 92RU3N3Y1O
Equate Anti Diarrheal Anti Gas Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWALMART INC.23af573f-8d40-6b82-e063-6394a90aabab2025-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC5dcd50ae-370d-4e49-b981-db42b86c2ecb2025-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Gas Relief SoftgelSIMETHICONECVS PHARMACY, INCde059bd9-40de-432d-9370-5d1e53bd89ac2024-12-30WarningsExact identifier
unii: 92RU3N3Y1O
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONETopco Associates, LLCc90d68a0-22e1-4a37-8487-16ecdc431ede2024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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