Home NDC 68992-3040-01 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 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 68992-3040-1 EnvarsusXR 1 in 1 POUCH TABLET, EXTENDED RELEASE 1 16 68992-3040-1 EnvarsusXR 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 68992-3040-3 EnvarsusXR 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 16 68992-3040-3 EnvarsusXR 1 in 1 POUCH TABLET, EXTENDED RELEASE 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68992-3040 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 20 of 36 · 710 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Gas Relief Cherry Flavor SIMETHICONE Discount Drug Mart, Inc 2df821f6-e4b5-89ae-e063-6394a90ad416 2025-02-24 Warnings Exact identifier unii: 92RU3N3Y1O Gas relief SIMETHICONE Discount Drug Mart, Inc 2df9117a-97cc-532d-e063-6294a90a1a9c 2025-02-20 Warnings Exact identifier unii: 92RU3N3Y1O DERMASIL DRYSKIN DIMETHICONE Fantasia Beauty LLC 8a49f4be-8a73-41ca-86f4-11a707b2987a 2025-02-18 Warnings Exact identifier unii: 92RU3N3Y1O XtraCare Oatmeal Daily Moisturizing 8 oz DIMETHICONE Rejoice International Inc. c055d5fb-7398-26e4-e053-2995a90acd41 2025-02-13 Warnings Exact identifier unii: 92RU3N3Y1O XtraCare Oatmeal Daily Moisturizing 8 oz DIMETHICONE Rejoice International Inc. c0670819-830e-4082-e053-2a95a90adadc 2025-02-13 Warnings Exact identifier unii: 92RU3N3Y1O Alike Daily Moisturizing DIMETHICONE Rejoice International Inc. 71b07d46-ff5b-b5ae-e053-2a95a90a8e71 2025-02-12 Warnings Exact identifier unii: 92RU3N3Y1O Ultra Strength Gas Relief SIMETHICONE BETTER LIVING BRANDS, LLC eb4bef2c-15dd-434a-e053-2a95a90a616f 2025-02-12 Warnings Exact identifier unii: 92RU3N3Y1O Maximum Strength Antacid Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c4fc835-a9ad-2666-e063-6394a90a20ac 2025-02-12 Warnings Exact identifier unii: 92RU3N3Y1O Maximum Strength Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c5081a6-367f-28bc-e063-6294a90a459e 2025-02-12 Warnings Exact identifier unii: 92RU3N3Y1O Regular Strength Antacid Antigas ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c503a99-91da-59f3-e063-6394a90a32ba 2025-02-12 Warnings Exact identifier unii: 92RU3N3Y1O Ultra Strength Gas Relief SIMETHICONE KROGER COMPANY ea1c4aa8-bde6-2072-e053-2995a90a93ba 2025-02-10 Warnings Exact identifier unii: 92RU3N3Y1O XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International f99606f6-83bc-436e-aa21-53e77eb87b9c 2025-02-09 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE 250 mg Anti-gas SIMETHICONE CVS Pharmacy, Inc. 63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5 2025-02-06 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief Cherry SIMETHICONE H E B 1894fa42-4aaf-2d17-e063-6394a90a3962 2025-02-06 Warnings Exact identifier unii: 92RU3N3Y1O Gas relief SIMETHICONE Guardian Drug Company a5c7c175-1fb7-4b4b-9ba1-b1df1251305c 2025-02-06 Warnings Exact identifier unii: 92RU3N3Y1O Anti-Diarrheal/Anti-Gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Harris Teeter, LLC 2c4f882b-89d5-42ce-e063-6294a90a5fbe 2025-02-05 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief SIMETHICONE Harris Teeter, LLC 2c3a05de-6690-f49a-e063-6394a90a9085 2025-02-05 Warnings Exact identifier unii: 92RU3N3Y1O Infants Gas relief SIMETHICONE Harris Teeter, LLC 2c39de90-4896-8a85-e063-6394a90af677 2025-02-05 Warnings Exact identifier unii: 92RU3N3Y1O Curist Gas Relief Maximum Strength SIMETHICONE Little Pharma, Inc. dc15a8e6-8924-f5c2-e053-2a95a90ab2c0 2025-02-04 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief Cherry SIMETHICONE Harris Teeter, LLC 2bd9ebda-520c-691a-e063-6294a90af7d3 2025-02-04 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.