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 26 of 36 · 710 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Simethicone SIMETHICONE Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 0f9639fa-e1d0-460d-bc46-714a01cd9811 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone SIMETHICONE Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 852cec3b-6564-46b2-afe5-ecef31424237 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Ultra Strength Gas Relief SIMETHICONE Walgreen Co. d33e413d-4add-459f-ba46-c23b49cfcc87 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE Walgreen Co. d87a20d4-dd1d-4897-9321-f81df2cfbcc7 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Ultra Strength Gas Relief SIMETHICONE Walgreen Co. b14b647f-d729-47df-879d-ca08a30b995e 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Ultra Strength Gas Relief SIMETHICONE Wal-Mart Stores Inc 206d57ec-c854-496e-af53-7d8b2a208d85 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone SIMETHICONE WALGREEN CO. 4d523979-e3ae-47e8-9092-00fdffc8bb0b 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE Wal-Mart Stores Inc 69351cf9-3092-45ca-8b84-83e3737fa8d4 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone SIMETHICONE WALMART INC. 79a9e0a3-9199-4397-ab29-b8a9c843cdf8 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Maximum Strength Gas Relief SIMETHICONE FOODHOLD U.S.A., LLC c37def6e-bb10-41ba-8bce-b06c09edbe9f 2024-11-21 Warnings Exact identifier unii: 92RU3N3Y1O Gas-Aid SIMETHICONE Leosons Overseas Corp d271bfcb-bf13-4a97-bc03-f1824826f15a 2024-11-19 Warnings Exact identifier unii: 92RU3N3Y1O Gas-Aid Drops for infants SIMETHICONE Leosons Overseas Corp 06665701-5f1c-4f8f-8775-e0a4a9ef2029 2024-11-19 Warnings Exact identifier unii: 92RU3N3Y1O TiZO Photoceutical Environmental Skin Protectant DIMETHICONE Fallien Cosmeceuticals, LTD 84a3299d-9b98-492e-a83f-ebd72ec58f8d 2024-11-14 Warnings Exact identifier unii: 92RU3N3Y1O Mag-AL Plus XS ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE PAI Holdings, LLC dba PAI Pharma db0c47ab-5296-4195-9fa6-2e338b665094 2024-11-12 Warnings Exact identifier unii: 92RU3N3Y1O ABC Arbonne Baby Care Diaper Rash DIMETHICONE AND ZINC OXIDE Arbonne International, LLC dd1d8198-bb9d-4508-a971-ae3bc624cdd1 2024-11-08 Warnings Exact identifier unii: 92RU3N3Y1O Aveeno Baby Daily Moisture with Coconut Oil and Shea Butter DIMETHICONE Kenvue Brands LLC eb71f8b1-bbcd-f338-e053-2995a90a80f1 2024-11-05 Warnings Exact identifier unii: 92RU3N3Y1O Aveeno Skin Relief Moisturizing Fragrance Free DIMETHICONE Kenvue Brands LLC 1bad1069-b169-4bc9-8eb8-5123d57f74e5 2024-11-05 Warnings Exact identifier unii: 92RU3N3Y1O Aveeno Skin Relief Moisturizing Fragrance Free DIMETHICONE Kenvue Brands LLC e0d9b055-be7a-8bba-e053-2995a90ab9e3 2024-11-05 Warnings Exact identifier unii: 92RU3N3Y1O Aveeno Baby Daily Moisture DIMETHICONE Kenvue Brands LLC 3879110f-ba83-446b-b580-f8eaa859789d 2024-11-05 Warnings Exact identifier unii: 92RU3N3Y1O Aveeno Daily Moisturizing DIMETHICONE Kenvue Brands LLC 70593b0c-c41b-4294-9bfa-42003ba1e3e4 2024-11-05 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.