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-X Total Relief Maximum Strength | CALCIUM CARBONATE, SIMETHICONE | Haleon US Holdings LLC | edb0f11a-bdb7-484d-9257-09ff47b0fca4 | 2025-07-15 | Warnings | 92RU3N3Y1O |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | WALGREEN COMPANY | 7cd9234e-d1cc-4cce-e053-2991aa0a457e | 2025-07-09 | Warnings | 92RU3N3Y1O |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Major Pharmaceuticals | 1bc90fa7-fcce-4a9b-862f-f30ab602ecab | 2025-07-07 | Warnings | 92RU3N3Y1O |
| Curist Gas Relief | SIMETHICONE | Little Pharma. Inc. | 3948c0e5-4ee7-5443-e063-6294a90ad6ae | 2025-07-06 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Bryant Ranch Prepack | 54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6 | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Exemax Cream | DIMETHICONE, ALLANTOIN | PureTek Corporation | 38e79055-df84-d314-e063-6394a90ac95f | 2025-07-01 | Warnings | 92RU3N3Y1O |
| Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Rising Pharma Holdings, Inc. | 982129d4-3cbf-4793-a861-d6c8f34bedc3 | 2025-07-01 | Warnings | 92RU3N3Y1O |
| Procure Dimethicone 5% | DIMETHICONE | Twin Med LLC | 38a7e4af-997d-549e-e063-6394a90a0bd6 | 2025-06-28 | Warnings | 92RU3N3Y1O |
| anti diarrheal anti gas | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | H E B | 35cff261-932e-4b2e-ab21-80969c27fa92 | 2025-06-27 | Warnings | 92RU3N3Y1O |
| Simethicone 125 mg | SIMETHICONE | ATLANTIC BIOLOGICALS CORP. | 4ce98db3-c7a6-4627-88c5-9de302a53188 | 2025-06-27 | Warnings | 92RU3N3Y1O |
| GNP Regular Strength Gas Relief | DIMETHICONE | ATLANTIC BIOLOGICALS CORP. | b31257ef-489b-4067-9cc6-8a593d983958 | 2025-06-24 | Warnings | 92RU3N3Y1O |
| Silicone Scar Cream | DIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOIN | Yunqi Cosmetics (Shenzhen) Co., Ltd | 37d02d8c-fbb5-5ba5-e063-6294a90a43ac | 2025-06-17 | Warnings | 92RU3N3Y1O |
| Diabecin HR | LIDOCAINE HCL, BENZALKONIUM CHLORIDE | PureTek Corporation | 36c60fe2-5b7b-83dd-e063-6294a90ad467 | 2025-06-10 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Accord Healthcare Inc. | bd447ffa-9196-4c3c-accf-5adf29b84665 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | American Health Packaging | 2faf291e-1d62-412a-a05e-e992cb7def6a | 2025-05-30 | Warnings | 92RU3N3Y1O |
| TEENY TUMMY Gas Relief Drops | SIMETHICONE | ATLANTIC BIOLOGICALS CORP | 376660a2-becb-48cf-a9f5-6a76a8b8ca70 | 2025-05-30 | Warnings | 92RU3N3Y1O |
| Gas-X Ultimate Strength Softgels | SIMETHICONE | Haleon US Holdings LLC | 24b777e5-f0b5-400d-8ca9-ae0c04b8503b | 2025-05-20 | Warnings | 92RU3N3Y1O |
| GERI-LANTA ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | ATLANTIC BIOLOGICALS CORP. | 043207dd-5e1c-4c78-b75a-7d341d71b117 | 2025-05-12 | Warnings | 92RU3N3Y1O |
| SUKKHI Polyamino Sugar Condensate Massage Cream | SUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 34aaf4ef-26dc-f87e-e063-6394a90a9a59 | 2025-05-08 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.