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 | 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 |
|---|---|---|---|---|---|---|
| 68992-3040-1 | 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 | 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68992-3040-1 | EA - Each | 68992-3040 | 8a9a3060-891a-494c-a738-d8fea61368d8 | 1 | 2015-10-02 |
| 68992-3040-3 | EA - Each | 68992-3040 | 8a01cf3e-c6af-482c-ac4d-a6a5849e648c | 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 |
|---|---|---|---|---|---|---|
| Gas Relief | SIMETHICONE | Best Choice (Valu Merchandisers Company) | 23eda70b-ff1e-4b4e-9f9e-034ef101cd68 | 2024-02-20 | Warnings | 92RU3N3Y1O |
| Anti-Gas Ultra Strength | SIMETHICONE | Best Choice (Valu Merchandisers Company) | f74d9882-cc99-41b6-b851-ce89d28f33df | 2024-02-15 | Warnings | 92RU3N3Y1O |
| Blistex Medicated Mint Balm | DIMETHICONE, OCTINOXATE, AND OCTISALATE | Blistex Inc | 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9 | 2024-02-09 | Warnings | 92RU3N3Y1O |
| Blistex Medicated Berry Balm | DIMETHICONE, OCTINOXATE, AND OCTISALATE | Blistex Inc | 827365b3-b3a5-4472-9add-f822362c4731 | 2024-02-09 | Warnings | 92RU3N3Y1O |
| Blistex Medicated Lip Balm | DIMETHICONE, OCTINOXATE, AND OCTISALATE | Blistex Inc | 8b4160ed-8889-4e3a-947f-a56c3324dbbe | 2024-02-09 | Warnings | 92RU3N3Y1O |
| tacrolimus | TACROLIMUS EXTENDED-RELEASE CAPSULES | Chengdu Suncadia Medicine Co., Ltd. | 08cf2861-2483-405d-a872-a88a5c235f9a | 2024-02-07 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| REGULAR STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fe04c244-d9b8-2800-e053-6294a90aeedc | 2024-02-06 | Warnings | 92RU3N3Y1O |
| Mylanta Classic | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE | Infirst Healthcare Inc. | 10a4cf29-39ed-87c3-e063-6394a90a4973 | 2024-02-05 | Warnings | 92RU3N3Y1O |
| Mylanta Vanilla Caramel | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE | Infirst Healthcare Inc. | 10a66d74-74b4-3f8d-e063-6394a90a7f00 | 2024-02-05 | Warnings | 92RU3N3Y1O |
| Right Remedies Maximum Strength Gas Relief Softgel | SIMETHICONE | Strive Pharmaceuticals Inc. | 032b3a89-1bc4-4f38-ba9e-0a4840215330 | 2024-02-05 | Warnings | 92RU3N3Y1O |
| XtraCare Skin Relief Oatmeal Daily Moisturizing | DIMETHICONE | Rejoice International | 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc | 2024-01-29 | Warnings | 92RU3N3Y1O |
| GENTEAL TEARS | DEXTRAN 70, GLYCERIN, HYPROMELLOSE | A-S Medication Solutions | a2b715e9-332d-4f0b-b8e5-ebc000681586 | 2024-01-21 | Warnings | 3NXW29V3WO |
| EIGHT HOUR NIGHT | DIMETHICONE | REVLON | b3b277f9-565a-636c-e053-2995a90a94d2 | 2024-01-12 | Warnings | 92RU3N3Y1O |
| Maximum Strength Gas Relief Softgel | SIMETHICONE | Cardinal Health 110, LLC. DBA Leader | 57043cae-a8db-4eff-835c-5995e8aea924 | 2024-01-11 | Warnings | 92RU3N3Y1O |
| D02 DIGESTIVE DRAINAGE | ALOE, ACTIVATED CHARCOAL, COLCHICUM AUTUMNALE BULB, COLLINSONIA CANADENSIS ROOT, CUCURBITA PEPO FLOWER, DRYOPTERIS FILIX-MAS ROOT, INDOLE, SKIM MILK, LYCOPODIUM CLAVATUM SPORE, ACHILLEA MILLEFOLIUM, SODIUM SULFATE, FRANGULA PURSHIANA BARK, SCROPHULARIA NODOSA, SKATOLE, TARAXACUM OFFICINALE, TARTARIC ACID | Apex Energetics Inc. | ba8734bf-920c-0ce4-e053-2a95a90a0705 | 2024-01-08 | Warnings | W4888I119H |
| GAS RELIEF EXTRA STRENGTH | SIMETHICONE | YYBA CORP | cc79435e-6d4b-b283-e053-2995a90a8db3 | 2024-01-03 | Warnings | 92RU3N3Y1O |
| Childrens Mylicon All in One Tummy Relief for Kids | ANTACID AND ANTIGAS | Infirst Healthcare Inc. | 0952eba8-6de2-4a77-956d-339fab437472 | 2024-01-01 | Warnings | 92RU3N3Y1O |
| Mylanta Maximum Strength Vanilla Caramel Flavor | ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | ace5cae4-3a78-41c3-987d-59ce22dca2ac | 2024-01-01 | Warnings | 92RU3N3Y1O |
| Mylicon Infants Gas Relief Original | SIMETHICONE | Infirst Healthcare | 395be942-d883-4bcb-8811-6fe1521d5a92 | 2024-01-01 | Warnings | 92RU3N3Y1O |
| Mylicon Infants Gas Relief Dye Free | SIMETHICONE | Infirst Healthcare | 3324139a-ed22-43af-859d-e7af19a24ee9 | 2024-01-01 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.