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 | 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 | 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 | 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68992-3075-1 | EA - Each | 68992-3075 | 3681cbb4-7b0f-4f39-8f3b-1845a3ef869b | 1 | 2015-10-02 |
| 68992-3075-3 | EA - Each | 68992-3075 | 4ec4185d-6a36-48e0-834a-91acf2494935 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mylanta Fall Harvest Collection Spiced Apple Cider | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 5a6040ff-1779-3215-e063-6294a90aaab1 | 2026-08-15 | Warnings | 92RU3N3Y1O |
| Mylanta Fall Harvest Collection Pumpkin Spice | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 5a60a221-5b37-806e-e063-6394a90a5ccc | 2026-08-15 | Warnings | 92RU3N3Y1O |
| CVS PHARMACY Extra Strength Gas Relief | SIMETHICONE ANTIGAS | CVS | b0fc2f24-cd63-4bb2-b9bb-a73449bcc169 | 2026-08-13 | Warnings | 92RU3N3Y1O |
| CVS PHARMACY Extra Strength | SIMETHICONE | CVS | 98db6216-897c-4cf6-a4b7-b913ae3a2496 | 2026-08-13 | Warnings | 92RU3N3Y1O |
| CVS PHARMACY Gas relief | SIMETHICONE | CVS | c2a3a978-c957-4453-88b3-53f4e80a2465 | 2026-08-13 | Warnings | 92RU3N3Y1O |
| Dr. Shitong Photon Energy Eye Care Liquid | TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58ace434-55ef-17ef-e063-6294a90aa878 | 2026-08-10 | Warnings | 3NXW29V3WO |
| WinCo FOODS Extra Strength Gas Relief | SIMETHICONE | WINCO FOODS, LLC | e2caf17a-a807-47f6-ab85-8e15a4679db4 | 2026-08-07 | Warnings | 92RU3N3Y1O |
| Extra Strength Gas Relief | SIMETHICONE | Shield Pharmaceuticals Corp | 55952af9-c3c1-452f-82c8-06f01dc4f0af | 2026-08-07 | Warnings | 92RU3N3Y1O |
| AMAZON EXTRA STRENGTH | SIMETHICONE | AMAZON.COM SERVICES LLC | 705489ce-ac7c-44a8-8298-ead19824582e | 2026-08-06 | Warnings | 92RU3N3Y1O |
| Gencare-Gas Relief | SIMETHICONE 180 MG | PIONEER LIFE SCIENCES, LLC | b7f2d5db-c1b7-4c01-8ee6-017e4b9f1425 | 2026-08-04 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Aphena Pharma Solutions - Tennessee, LLC | da0cc98e-1692-405a-ab81-420d6f9df6de | 2026-07-31 | Warnings | 92RU3N3Y1O |
| INFANTS GAS RELIEF DROPS | SIMETHICONE | RELIABLE 1 LABORATORIES | b479bf22-3469-7916-e053-2995a90addc8 | 2026-07-30 | Warnings | 92RU3N3Y1O |
| Gethorey Vein Target Microneedle Patch | ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57593145-a874-15d9-e063-6294a90a77d9 | 2026-07-24 | Warnings | 92RU3N3Y1O |
| DERMFREE Vein Target Microneedle Patch | ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57449e29-ec46-9c30-e063-6394a90a7b4a | 2026-07-23 | Warnings | 92RU3N3Y1O |
| DERMFREE VARICOSE VEINS | DIMETHICONE 3% VARICOSE VEINS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5a2d1d-9e84-18eb-e063-6394a90a97ee | 2026-07-21 | Warnings | 92RU3N3Y1O |
| Best Choice | SIMETHICONE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 245504a6-d2fc-4e05-871b-bab03f34e154 | 2026-07-17 | Warnings | 92RU3N3Y1O |
| Best Choice Extra Strength | SIMETHICONE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | a41b2895-abbe-4cf1-9c42-0b5e902d298b | 2026-07-17 | Warnings | 92RU3N3Y1O |
| Best Choice Extra Strength Berry Flavor | CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 529d7da6-5997-41f5-bfb8-33d2bbdce78e | 2026-07-17 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Stellon Biotech Inc. | 6b89e8a4-9f11-42e3-8e79-fe617e7c461f | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Mederma Stretch Marks Therapy | DIMETHICONE | PMI Branded Pharmaceuticals, Inc. | 0f2918e3-9615-40e3-ab7e-6bfbe022e03c | 2026-07-16 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.