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 |
|---|---|---|---|---|---|---|
| Cardinal Health Infants Gas Relief | SIMETHICONE | CARDINAL HEALTH | e0dec270-dabb-4289-b5e0-bf37f9ddcbcd | 2025-10-14 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS OINTMENT 0.1% | Encube Ethicals, Inc. | 43b38551-6c5e-48a4-a453-9286f1c16b34 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| HealthWise Medicated Diabetic Foot Cream | DIMETHICONE, PETROLATUM | Veridian Healthcare | 164f4cd8-975a-40d5-e063-6394a90ae7d5 | 2025-10-02 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Bryant Ranch Prepack | a2e55495-10cc-4f6e-b866-1e7d6e45888b | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Quality Choice Infants Gas Relief Dye Free | SIMETHICONE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | 2025-08-23 | Warnings | 92RU3N3Y1O |
| CVS Health Gas Relief SOFTGEL | SIMETHICONE | CVS Pharmacy, Inc | 2911cac8-45ec-1294-e063-6294a90a4a74 | 2025-08-22 | Warnings | 92RU3N3Y1O |
| Awaken Moisturizing Cream | DIMETHICONE | Guangzhou Danting Bath&Body Care Industry Co. Ltd | 486c7f05-708a-44a1-8fc0-78344f5018db | 2025-08-21 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | BJWC (Berkley & Jensen / BJ's) | 2f32dde8-502e-eefa-e063-6294a90abf20 | 2025-08-19 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Mylan Pharmaceuticals Inc. | 45af3eda-caaa-4478-9372-95aa65adc9b3 | 2025-08-15 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| ProCure Skin Repair Cream | DIMETHICONE 1.5% | Twin Med LLC | 3ba3d3b3-ab13-ea80-e063-6394a90ad459 | 2025-08-05 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Strides Pharma Science Limited | ed7d1495-3585-409d-94f1-b3d2469d222c | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| TopCare health EXTRA STRENGTH Gas Relief SOFTGEL | SIMETHICONE | Topco Associates LLC | 2ea0eb22-f679-d136-e063-6294a90a1dfe | 2025-08-01 | Warnings | 92RU3N3Y1O |
| MINTOX MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | ATLANTIC BIOLOGICALS CORP. | ac6a47e7-972f-4b82-96da-89926d345e9f | 2025-07-31 | Warnings | 92RU3N3Y1O |
| Maximum Strength Antacid and Antigas | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Meijer, Inc. | 30a0455d-63e0-95cc-e063-6394a90ada6b | 2025-07-30 | Warnings | 92RU3N3Y1O |
| SIMETHICONE INFANT Gas Relief Drops | SIMETHICONE | AARNA USA Inc. | 9b0fde90-35ae-498e-99cc-d120f1a87182 | 2025-07-29 | Warnings | 92RU3N3Y1O |
| Anti-Diarrheal/Anti-Gas Caplets | LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG | YYBA CORP | 46f5c653-eec2-4729-8aaa-79f2e188eac3 | 2025-07-24 | Warnings | 92RU3N3Y1O |
| Dimethicone 1 Skin Protectant | DIMETHICONE | Universal Distribution Center LLC | 2c5b96b9-24d6-4223-a63d-fe83d7c02368 | 2025-07-24 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | MylanInstitutional Inc. | 5f742224-618e-4f4c-bdec-7693be99c697 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Medicated Peppermint Lip Balm | DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE | Blistex Inc | 5d48a6fa-ddce-47c3-9b09-1f3abb695017 | 2025-07-18 | Warnings | 92RU3N3Y1O |
| Gas Relief Ultra Strength | SIMETHICONE | Rugby Laboratories, Inc. | 24731f4b-ca2b-483f-beed-dfc8104f8133 | 2025-07-18 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.