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 |
|---|---|---|---|---|---|---|
| Tacrolimus | TACROLIMUS | CONCORD BIOTECH LIMITED | 823b11cb-d873-4017-a861-d22d2c5a8a49 | 2023-11-10 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| MAXIMUM STRENGTH ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fd00ead8-026c-6610-e053-6394a90a0f11 | 2023-11-08 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fd67566a-1078-019d-e053-6394a90a415c | 2023-11-08 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fd7a0a90-6570-c722-e053-6394a90a03f4 | 2023-11-08 | Warnings | 92RU3N3Y1O |
| ANTACID ANTIGAS NTA | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5d6916ec-e87f-6421-e053-2991aa0a3364 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5d68366d-fee9-2acf-e053-2991aa0a7e4b | 2023-11-07 | Warnings | 92RU3N3Y1O |
| ANTACID ANTIGAS NTA | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5d7ed0c5-911c-299a-e053-2a91aa0aae56 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5e1eed65-0d4c-2d02-e053-2991aa0a95c1 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | CARDINAL HEALTH | 7ee3618a-43c8-2ccc-e053-2a91aa0a8115 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| ANTACID MINT | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CARDINAL HEALTH | af5ea189-2118-4ffd-e053-2995a90aecfd | 2023-11-07 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CARDINAL HEALTH | b1a3cef7-a05e-bb39-e053-2995a90abfb5 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID AND GASRELIEF | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | GOODSENSE | a9654a96-9bfd-60ea-e053-2995a90ae38d | 2023-11-07 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID MINT | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | H E B | abfe6688-f852-ba8e-e053-2995a90a49a3 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| ANTACID AND GASRELIEF | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | GOODSENSE | a9654a96-9bf9-60ea-e053-2995a90ae38d | 2023-11-07 | Warnings | 92RU3N3Y1O |
| ADVANCED ANTACID MINT | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | GOODSENSE | a964da1d-e1e3-94a8-e053-2a95a90ac804 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | KROGER COMPANY | a1b132d5-00d0-55c1-e053-2a95a90a8d27 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID MINT | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | KROGER COMPANY | b9e5fc3f-caf0-84c4-e053-2a95a90af655 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| ANTACID PLUS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | BETTER LIVING BRANDS LLC | b8e233c7-eaa0-b1ec-e053-2a95a90a0549 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| Antacid Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | BETTER LIVING BRANDS, LLC | b93191e8-28a7-6c8f-e053-2995a90ac327 | 2023-11-07 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ADVANCED ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | DOLGENCORP, LLC | b6993a5a-6144-ba65-e053-2995a90aee9b | 2023-11-07 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.