Home NDC 68992-3075-01 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 Label Manufacturer Effective date Type Envarsus XR Veloxis Pharmaceuticals, Inc | Rottendorf Pharma GmbH | Pharma Packaging Solutions, LLC dba Tjoapack, LLC 2025-02-26 HUMAN PRESCRIPTION DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68992-3075-1 EnvarsusXR 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 68992-3075-1 EnvarsusXR 1 in 1 POUCH TABLET, EXTENDED RELEASE 1 16 68992-3075-3 EnvarsusXR 1 in 1 POUCH TABLET, EXTENDED RELEASE 1 16 68992-3075-3 EnvarsusXR 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68992-3075 ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 16 Current NDC, Legacy NDC, 4 package rows 20250302_de2315b0-6344-43ac-9aea-3e3b68d828e7.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TACROLIMUS ACTIVE INGREDIENT WM0HAQ4WNM ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 TACROLIMUS ANHYDROUS ACTIVE MOIETY Y5L2157C4J ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC] 3 TARTARIC ACID INACTIVE INGREDIENT W4888I119H ENVARSUS 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 28 of 36 · 715 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GenRx Daily Defense Skin Repairing DIMETHICONE PureTek Corporation 7d2827fd-b40f-454b-bb60-54d77823b18c 2024-10-16 Warnings Exact identifier unii: 92RU3N3Y1O Equate Daily Moisturizing Dimethicone Skin Protectant DIMETHICONE Walmart Stores Inc. 8fda01f7-a52a-4a63-98ac-b32cb47947f3 2024-10-16 Warnings Exact identifier unii: 92RU3N3Y1O Hill Country Essentials DIMETHICONE H.E.B c51d8647-8af6-473a-b989-dfa6bfdc368d 2024-10-15 Warnings Exact identifier unii: 92RU3N3Y1O Target Up and Up Daily Moisturizing DIMETHICONE TARGET CORPORATION f118e0eb-1e66-50ab-e053-2995a90a2cb9 2024-10-14 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Accord Healthcare Inc. 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 2024-10-04 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM Melox ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Belmora LLC bfc78d44-dc90-4f69-85af-a23dd70c68d2 2024-10-04 Warnings Exact identifier unii: 92RU3N3Y1O Dimopair DIMETHICONE PureTek Corporation dc16af56-b97d-c17f-e053-2995a90a55a0 2024-10-01 Warnings Exact identifier unii: 92RU3N3Y1O Skin Repair Complex DIMETHICONE PureTek Corporation 1c3059c5-5f7e-264e-e054-00144ff8d46c 2024-10-01 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone 80 mg SIMETHICONE Proficient Rx LP a5e523b3-475e-4d28-a89c-c4325c59c939 2024-10-01 Warnings Exact identifier unii: 92RU3N3Y1O good sense gas relief SIMETHICONE L. Perrigo Company 14caaf5a-6877-40f9-af8f-fb48de94ecfe 2024-09-30 Warnings Exact identifier unii: 92RU3N3Y1O Advanced Eye Relief/ Redness Maximum Relief NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE Bausch & Lomb Incorporated 3c11285a-7e86-4b47-b1ee-e7d59858087d 2024-09-25 Warnings Exact identifier unii: 3NXW29V3WO Aveeno Baby Daily Moisture DIMETHICONE Kenvue Brands LLC b34c8e71-7fad-484c-b387-3c424f50b743 2024-09-19 Warnings Exact identifier unii: 92RU3N3Y1O Care One Gas Relief SIMETHICONE American Sales Company f42c8c2a-4ffd-465e-bb93-05ed65ba76f0 2024-09-15 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE Publix Super Markets Inc aafa7da9-53d7-478a-805e-e68cdf54ed2b 2024-09-14 Warnings Exact identifier unii: 92RU3N3Y1O basic care gas relief SIMETHICONE Amazon.com Services LLC 6cd13797-207b-41fa-8dc1-5688f6b86149 2024-09-14 Warnings Exact identifier unii: 92RU3N3Y1O meijer EXTRA STRENGTH Gas Relief SOFTGEL SIMETHICONE Meijer, Inc. 1befc6cb-a5ad-b950-e063-6394a90a5de3 2024-09-12 Warnings Exact identifier unii: 92RU3N3Y1O Aveeno Skin Relief Moisturizing Fragrance Free DIMETHICONE Kenvue Brands LLC 65476a2a-8cd4-4477-ac27-9a06f41e4711 2024-09-09 Warnings Exact identifier unii: 92RU3N3Y1O meijer ULTRA STRENGTH Gas Relief SOFTGEL SIMETHICONE Meijer, Inc. 1bdbea4c-52f6-f855-e063-6394a90ae4fc 2024-09-06 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Bryant Ranch Prepack 3dc347e3-9bfd-4910-adb5-24e979208345 2024-09-05 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM Tacrolimus TACROLIMUS Bryant Ranch Prepack 27154d3a-eec5-4000-a4ff-bfbfe27eb806 2024-09-05 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.