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 21 of 36 · 715 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Extra Strength Gas Relief SIMETHICONE TARGET CORPORATION f6ff3b61-8a47-14ec-e053-6294a90a2df8 2025-01-31 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Quallent Pharmaceuticals Health LLC 23b7b4d7-1431-e9f2-43ba-eabd169dc2dd 2025-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM Gas relief Anti-gas SIMETHICONE CVS 2bc548d2-7176-333b-e063-6394a90aae01 2025-01-29 Warnings Exact identifier unii: 92RU3N3Y1O Ultrastrength Gas Relief SIMETHICONE SOFT GELATIN CAPSULES CVS PHARMACY, INC 24ceba32-eb30-902f-e063-6394a90a9fd5 2025-01-29 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief Cherry Creme SIMETHICONE CVS 2bc522c8-9df0-05b4-e063-6394a90af60c 2025-01-27 Warnings Exact identifier unii: 92RU3N3Y1O Baby XtraCare Oatmeal DIMETHICONE Rejoice International 0049462b-ff31-440f-9244-b61153625bca 2025-01-23 Warnings Exact identifier unii: 92RU3N3Y1O HEB Gas Relief Extra Strength Peppermint SIMETHICONE H E B 52f6db66-ce4c-40dc-b483-6ba83977cd8b 2025-01-20 Warnings Exact identifier unii: 92RU3N3Y1O Aluminum Hydroxide, Magnesium Hydroxide and Simethicone ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE Everpharm LLC 2bda74cb-e77d-46bb-e063-6394a90af580 2025-01-16 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone 125 mg SIMETHICONE Reliable 1 Laboratires LLC 330aed4b-7109-09b8-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone 80 mg SIMETHICONE Reliable 1 Laboratories LLC 32fb242b-7051-072c-e054-00144ff88e88 2025-01-15 Warnings Exact identifier unii: 92RU3N3Y1O Skin Barista 2in1 White Body Perfection DIMETHICONE Pioom Cosmetic Co.,ltd 2d7fc20c-31a7-195b-e054-00144ff88e88 2025-01-15 Warnings Exact identifier unii: 92RU3N3Y1O SIMETHICONE SIMETHICONE Aphena Pharma Solutions - Tennessee, LLC 5df94be7-0bc9-4be1-9982-8193e3a3c8ef 2025-01-10 Warnings Exact identifier unii: 92RU3N3Y1O Antiflatulent SIMETHICONE Aphena Pharma Solutions - Tennessee, LLC dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea 2025-01-10 Warnings Exact identifier unii: 92RU3N3Y1O Anti-Gas Strip SIMETHICONE Calmour c1576ee9-69ff-41ff-b2d0-7703c8fa8edd 2025-01-09 Warnings Exact identifier unii: 92RU3N3Y1O Anti-Diarrheal/Anti-Gas Multi-Symptom Relief LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG Wal-Mart Stores, Inc. a4d5dd69-22cf-4d00-b539-133886c09e37 2025-01-09 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone SIMETHICONE AMZ789 LLC bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2 2025-01-08 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone 250mg SIMETHICONE 250MG AMZ789 LLC fcc2ef8b-9181-2c59-e053-6394a90adcc1 2025-01-08 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.