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 4 of 36 · 715 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gelfos-M ALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONE Masaem Company 56b9a769-08fb-738f-e063-6294a90a9eb2 2026-07-16 Warnings Exact identifier unii: 92RU3N3Y1O FEVIA Gas Control SIMETHICONE VIVUNT PHARMA LLC 4bd53a70-3ba0-364c-e063-6394a90a7a64 2026-07-16 Warnings Exact identifier unii: 92RU3N3Y1O FEVIA Gas Control SIMETHICONE VIVUNT PHARMA LLC 4b1d1bce-eeef-b790-e063-6294a90a166e 2026-07-16 Warnings Exact identifier unii: 92RU3N3Y1O Tacrolimus TACROLIMUS Major Pharmaceuticals 213f6047-f897-48a7-b78a-45d7124f2f16 2026-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WM0HAQ4WNM Simethicone TARGET BERRY BLAST ANTACID HBG CHEW Target 5245af45-77c7-c95f-e063-6294a90a24f7 2026-07-15 Warnings Exact identifier unii: 92RU3N3Y1O Mederma PM DIMETHICONE PMI Branded Pharmaceuticals, Inc. 26737285-f6ae-47eb-9019-33f1cfce3029 2026-07-15 Warnings Exact identifier unii: 92RU3N3Y1O MEDERMA STRETCH MARKS THERAPY DIMETHICONE L. Perrigo Company e9366775-e85b-4403-a2c5-12d9fb3cc3fa 2026-07-15 Warnings Exact identifier unii: 92RU3N3Y1O Remedy Barrier Cream Cloths Fragrance Free DIMETHICONE Medline Industries, LP 00e0cd4a-6049-408a-ab3f-9edf97e6438a 2026-07-14 Warnings Exact identifier unii: 92RU3N3Y1O Maximum Strength Antacid Mint SIMETHICONE Guardian Drug Company 48ec3132-17cf-1de9-e063-6294a90aa407 2026-07-14 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE CARDINAL HEALTH 110, LLC. DBA LEADER 70000 cce7f7db-99b8-4d7d-ac77-43da6323ebe1 2026-07-14 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE Rite Aid Corporation 43e94ffc-a3ec-4a16-98db-b000a6dc4230 2026-07-10 Warnings Exact identifier unii: 92RU3N3Y1O Drs. DIAPER RASH MAXIMUM STRENGTH ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 161ba174-1b13-83cd-e063-6394a90af19c 2026-07-09 Warnings Exact identifier unii: 92RU3N3Y1O Artificial Tears ARTIFICIAL TEARS AvPAK f18bebf2-1936-658f-e053-2a95a90a5012 2026-07-07 Warnings Exact identifier unii: 3NXW29V3WO Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g) NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE) Reedfresh Co., LTD 55d703ca-ff9d-0dbc-e063-6294a90ab6b1 2026-07-05 Warnings Exact identifier unii: 92RU3N3Y1O DIMETHICONE SKIN PROTECTANT DIMETHICONE VIVE HEALTH LLC 5591a321-4831-1844-e063-6394a90a12d1 2026-07-01 Warnings Exact identifier unii: 92RU3N3Y1O RIGHT REMEDIES Extra Strength Gas Relief SIMETHICONE Strive Pharmaceuticals Inc. 2d651784-a17b-12bc-e063-6294a90a8ab2 2026-06-30 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief GAS RELIEF Chain Drug Marketing Association, Inc. 912f896b-ff49-40e6-b425-c314e0cbf48e 2026-06-30 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief SIMETHICONE Strategic Sourcing Services LLC 0add7687-f9d7-4f70-b9a8-1454db8a7caf 2026-06-29 Warnings Exact identifier unii: 92RU3N3Y1O Gas Relief Extra Strength SIMETHICONE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 447ee411-f4b9-4dd1-a3e0-36ad79bccbf9 2026-06-25 Warnings Exact identifier unii: 92RU3N3Y1O Comfort Shield Barrier DIMETHICONE Sage Products LLC cc08f571-84ae-4c2f-b09d-a83a8efc39f5 2026-06-23 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.