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 16 of 36 · 715 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join up and up extra strength gas relief chewables Extra Strength SIMETHICONE Target Corporation 0a015c48-680c-4de1-91e7-1c1145239d8e 2025-11-04 Warnings Exact identifier unii: 92RU3N3Y1O ADVANCED REGULAR STRENGTH ANTACID ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE WALGREEN COMPANY 5faf6229-b0fd-58df-e053-2a91aa0ab3bb 2025-10-30 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief SIMETHICONE SAFEWAY c8946bd2-6351-40e4-a139-d8214889bb4e 2025-10-29 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief SIMETHICONE ANTIGAS SAFEWAY cbbd43eb-1155-4e0d-bed4-32343f34b503 2025-10-29 Warnings Exact identifier unii: 92RU3N3Y1O meijer EXTRA STRENGTH Gas Relief SIMETHICONE Meijer, Inc 3e83bb0f-d909-08c3-e063-6294a90ae138 2025-10-29 Warnings Exact identifier unii: 92RU3N3Y1O PUBLIX Extra Strength SIMETHICONE PUBLIX SUPER MARKETS, INC 089d77c9-7aa0-4eee-8363-c47a2d5928cf 2025-10-28 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength gas relief SIMETHICONE PUBLIX SUPER MARKETS, INC, 029f9254-8cfd-4ea0-8691-2d87df450433 2025-10-28 Warnings Exact identifier unii: 92RU3N3Y1O Publix Infants Dye Free Gas Relief SIMETHICONE PUBLIX SUPER MARKETS, INC 2fe74800-a1f6-4774-9976-d6767ba34b49 2025-10-28 Warnings Exact identifier unii: 92RU3N3Y1O Remedy Nutrashield DIMETHICONE Medline Industries, LP ed8a08a7-594c-46e2-b70f-b75b2960141f 2025-10-28 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief SIMETHICONE Wal-Mart Stores,Inc., e6087f04-20bf-402c-892b-e64f778b0144 2025-10-27 Warnings Exact identifier unii: 92RU3N3Y1O Infants Gas Relief Drops SIMETHICONE Wal-Mart Stores,Inc., 966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157 2025-10-27 Warnings Exact identifier unii: 92RU3N3Y1O Boudreauxs Butt Barrier DIMETHICONE C.B. Fleet Company, Inc. 06a5af4d-40dd-42a4-8368-4d6a772d1b3a 2025-10-27 Warnings Exact identifier unii: 92RU3N3Y1O Infants SIMETHICONE RUGBY LABORATORIES c6fa71bc-de48-47f4-80c4-7d92643d2664 2025-10-25 Warnings Exact identifier unii: 92RU3N3Y1O Loperamide Hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE IMO-GEN LABS LLC 41d6dba5-e411-c8d2-e063-6294a90ae8fa 2025-10-23 Warnings Exact identifier unii: 92RU3N3Y1O PHAZYME SIMETHICONE C.B. Fleet Company, Inc. ea04f5a5-cf56-4176-a234-5a73e01ff218 2025-10-23 Warnings Exact identifier unii: 92RU3N3Y1O JAFRA Fruteria Coco Fresco Lip Balm DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 9895a320-8a74-4b27-9bf1-4b492f89888c 2025-10-21 Warnings Exact identifier unii: 92RU3N3Y1O JAFRA Fruteria So Citrico DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. a68d6cda-2268-440a-9ca6-677c4e3ea0e7 2025-10-21 Warnings Exact identifier unii: 92RU3N3Y1O JAFRA Fruteria Very Verde Lip Balm DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 4f0de70b-7ebe-4381-9b46-d5b334f426e0 2025-10-21 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Amneal Pharmaceuticals NY LLC 4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3 2025-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM Advanced Healing Diabetic Skin Care DIMETHICONE Eco-Logics, Inc. c6704d06-0311-406e-98a7-b8c8881aefd5 2025-10-18 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.