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 27 of 36 · 715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Daily Moisture with Coconut Oil and Shea ButterDIMETHICONEKenvue Brands LLCeb71f8b1-bbcd-f338-e053-2995a90a80f12024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC1bad1069-b169-4bc9-8eb8-5123d57f74e52024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLCe0d9b055-be7a-8bba-e053-2995a90ab9e32024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
basic care gas reliefSIMETHICONEAmazon.com Services LLCab1681df-aded-4b0c-9124-87196606183b2024-11-02WarningsExact identifier
unii: 92RU3N3Y1O
Good Sense Gas Relief Extra StrengthSIMETHICONEL. Perrigo Company6b2d8591-cc58-457e-92b6-c719eee856052024-11-02WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
unii: 92RU3N3Y1O
premier value infants gas reliefSIMETHICONEChain Drug Consortium7b887e53-a70a-4f33-9472-e1175b24400a2024-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Premier Value Extra StrengthSIMETHICONEPHARMACY VALUE ALLIANCE, LLCdf2b1b62-5bd2-4d02-86c2-537b965a8d202024-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
unii: 92RU3N3Y1O
Premier Value Multi Symptom Antacid Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEPharmacy Value Alliance LLC69e0c4a8-04ae-461b-bf47-4180bccd91d62024-10-25WarningsExact identifier
unii: 92RU3N3Y1O
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
unii: 92RU3N3Y1O
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
unii: 92RU3N3Y1O
SILICEA COMPLEX IIECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI CHLORICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUM, SILICONE (DIMETHICONE).BioActive Nutritional, Inc.df277f21-9e60-4c64-928a-b1d9251032822024-10-18WarningsExact identifier
unii: 92RU3N3Y1O
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
unii: 92RU3N3Y1O
TacrolimusTACROLIMUSAmerican Health Packaging93d03943-0655-44f6-b494-57bd1e336a342024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WM0HAQ4WNM
Meijer Skin Relieving MoisturizingDIMETHICONEMEIJER DISTRIBUTION, INC8e5be6b3-87e7-d958-e053-2a95a90a69612024-10-16WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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