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 30 of 36 · 710 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gas Relief Ultra Strength SIMETHICONE Walgreens 0050b639-5fb6-4503-ae73-e319cf037027 2024-06-26 Warnings Exact identifier unii: 92RU3N3Y1O THERA Moisturizing Body Shield DIMETHICONE McKesson Medical-Surgical Inc. 56869b64-11ee-4df6-8102-ce5818e0116e 2024-06-18 Warnings Exact identifier unii: 92RU3N3Y1O Dimethicone SKIN PROTECTANT McKesson 96886b33-44d4-5a2a-e053-2a95a90a505e 2024-06-18 Warnings Exact identifier unii: 92RU3N3Y1O Dimethicone BODY CLEANSER McKesson 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8 2024-06-14 Warnings Exact identifier unii: 92RU3N3Y1O Dr. Mom Butt Balm DIMETHICONE PETROLATUM Ferndale Laboratories, Inc. ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd 2024-06-13 Warnings Exact identifier unii: 92RU3N3Y1O ANTACID AND GASRELIEF ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE GOODSENSE a951fa64-7775-470e-e053-2995a90aefc4 2024-06-10 Warnings Exact identifier unii: 92RU3N3Y1O MINTOX MAXIMUM STRENGTH ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE NuCare Pharmaceuticals,Inc. 5b1f4c78-d42e-32c7-e053-2991aa0a1985 2024-06-04 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE Strategic Sourcing Services LLC 853f5f52-8fe1-473f-b68d-295115222120 2024-05-31 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Ultra Strength SIMETHICONE A-S Medication Solutions 708cbbf2-4923-4cbf-b71c-c8bb2ce80e63 2024-05-29 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Ultra Strength SIMETHICONE United Natural Foods, Inc. dba UNFI a7961933-9d74-4c18-8050-2cc13cb6725e 2024-05-23 Warnings Exact identifier unii: 92RU3N3Y1O Mylanta All-Family Multi Symptom Stomach Remedy CALCIUM CARBONATE, SIMETHICONE Infirst Healthcare Inc. 19118884-2016-e86e-e063-6294a90a370c 2024-05-22 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Ultra Strength SIMETHICONE Safeway, Inc. 8927d9eb-65b2-40f3-846c-dc9cd2884dea 2024-05-14 Warnings Exact identifier unii: 92RU3N3Y1O Maximum Strength Gas Relief SIMETHICONE TARGET CORPORATION f6ff50f5-4195-a61f-e053-6294a90a8bdf 2024-05-13 Warnings Exact identifier unii: 92RU3N3Y1O Monistat Complete Care Chafing Relief DIMETHICONE Insight Pharmaceuticals LLC 07d7c883-1fa3-4786-905c-a1fab649765e 2024-04-19 Warnings Exact identifier unii: 92RU3N3Y1O simethicone gas relief SIMETHICONE MOM Enterprises, LCC 536ecfdf-7124-502a-e054-00144ff8d46c 2024-04-09 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Ultra Strength SIMETHICONE H E B d83f2dcf-c8c6-4581-9406-6bad8d39d03e 2024-04-09 Warnings Exact identifier unii: 92RU3N3Y1O Gas-X Maximum Strength Softgels SIMETHICONE Haleon US Holdings LLC 45d1e373-0717-47df-9160-619c451666f4 2024-04-05 Warnings Exact identifier unii: 92RU3N3Y1O Gas-X Total Relief Maximum Strength CALCIUM CARBONATE, SIMETHICONE Haleon US Holdings LLC 62fc0a91-c44f-4546-a472-c183a2d95486 2024-04-05 Warnings Exact identifier unii: 92RU3N3Y1O Gas-X Ultra Strength AntiGas Softgels SIMETHICONE Haleon US Holdings LLC ee9a8404-0653-433f-90e5-7ac69bdab8df 2024-04-05 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Ultra Strength SIMETHICONE CVS Pharmacy bac06147-87ae-4aaa-a66b-4aeae6096d8d 2024-03-13 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.