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 13 of 36 · 715 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Target Antacid - Anti-Gas Relief Chews CALCIUM CARBONATE Target 964e357c-a8ab-09fa-e053-2a95a90a37c6 2025-12-20 Warnings Exact identifier unii: 92RU3N3Y1O Target Berry Lime HBG Chews CALCIUM CARBONATE Target 11fba65d-8a81-1227-e063-6294a90a11bd 2025-12-20 Warnings Exact identifier unii: 92RU3N3Y1O Target Gas Relief Chews Mixed Berry and Strawberry SIMETHICONE Target 11fd2ccd-3a2b-c141-e063-6394a90ab34f 2025-12-20 Warnings Exact identifier unii: 92RU3N3Y1O Artificial Tears GLYCERIN Geri-Care Pharmaceuticals, Corp 7cc437e3-bad9-59be-e053-2991aa0a1da3 2025-12-19 Warnings Exact identifier unii: 3NXW29V3WO Gas Relief Simethicone 125mg Softgel SIMETHICONE NUVICARE LLC b774c8e6-e68e-4a13-834d-7eba34c5c3e0 2025-12-19 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Simethicone 180mg Softgel SIMETHICONE NUVICARE LLC 51484644-eb45-4282-91c6-289169bcbaf6 2025-12-19 Warnings Exact identifier unii: 92RU3N3Y1O EXTRA STRENGTH gas relief SIMETHICONE KRAMER LABORATORIES d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb 2025-12-19 Warnings Exact identifier unii: 92RU3N3Y1O SIMETHICONE 80MG SIMETHICONE Cardinal Health 107, LLC 5e755184-0821-4f92-8f72-84726f7aa407 2025-12-18 Warnings Exact identifier unii: 92RU3N3Y1O Meijer Berry Lime Antacid HBG Chews CALCIUM CARBONATE Meijer 16efa685-5b74-2661-e063-6394a90ac506 2025-12-18 Warnings Exact identifier unii: 92RU3N3Y1O Meijer Max Gas 30ct SIMETHICONE Meijer 23f95dcf-3d4c-a119-e063-6394a90a5155 2025-12-18 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Ascend Laboratories, LLC 55467f4b-8437-43a3-b6d9-1bc2a13b4c11 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM Gas Relief SIMETHICONE CAPSULES USP, 125 MG Dr. Reddy's Laboratories Inc. b3069d83-5654-8469-302a-0f76c30e3976 2025-12-15 Warnings Exact identifier unii: 92RU3N3Y1O HealthWise Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 7ba0ac53-c78c-4a70-a977-a082f731919e 2025-12-15 Warnings Exact identifier unii: 92RU3N3Y1O Artificial Tears GLYCERIN NuCare Pharmaceuticals,Inc. 97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d 2025-12-15 Warnings Exact identifier unii: 3NXW29V3WO ULTRA STRENGTH Gas Relief Softgels SIMETHICONE Topco Associates LLC 42c449cc-a450-1796-e063-6294a90a762a 2025-12-13 Warnings Exact identifier unii: 92RU3N3Y1O Loperamide hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Bionpharma Inc. 9b0a802f-6fae-4142-ad2f-4b16ed67400e 2025-12-12 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Golden State Medical Supply, Inc. 34ec4989-6933-4237-ae1e-50a0cb90a2fe 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM EXTRA STRENGTH GAS RELIEF SIMETHICONE Geri-Care Pharmaceuticals, Corp b6701200-eb58-30f1-e053-2a95a90a032e 2025-12-10 Warnings Exact identifier unii: 92RU3N3Y1O Heartburn and gas fruit chews CALCIUM CARBONATE CVS Pharmacy 4a656a9f-8f34-69b7-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier unii: 92RU3N3Y1O CVS Mixed Berry Antacid HBG 54ct CALCIUM CARBONATE CVS Pharmacy e9204edb-e4d9-3975-e053-2995a90ac6a9 2025-12-07 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.