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 |
|---|---|---|---|---|---|---|
| GenTeal Tears (Moderate) | DEXTRAN 70, GLYCERIN, HYPROMELLOSE | Alcon Laboratories, Inc. | a2992597-3490-6a5c-be45-2b6fa15e1547 | 2023-12-15 | Warnings | 3NXW29V3WO |
| Mylanta One Antacid/Anti-Gas | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE | Infirst Healthcare Inc. | aa694e0d-7891-4870-8106-dd57f1e29fb4 | 2023-12-11 | Warnings | 92RU3N3Y1O |
| Mylanta One Antacid/Anti-Gas | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE | Infirst Healthcare Inc. | ed1b03f0-fabc-4c1c-8e6d-9f15c380300c | 2023-12-11 | Warnings | 92RU3N3Y1O |
| Mylanta Gas Minis Mint Flavor | SIMETHICONE | Infirst Healthcare Inc. | 5045b945-23ee-4c25-a32c-af3cd5045c73 | 2023-12-04 | Warnings | 92RU3N3Y1O |
| Mylanta Gas Minis Assorted Fruit Flavor | SIMETHICONE | Infirst Healthcare Inc. | c6db9af2-d457-477d-baa9-470ddbba5905 | 2023-12-04 | Warnings | 92RU3N3Y1O |
| Infants Non-staining Gas relief | SIMETHICONE | H E B | 99d94de2-9550-4d2d-99d4-1be0ef7b7880 | 2023-12-04 | Warnings | 92RU3N3Y1O |
| Childrens Mylicon Tummy Relief for Kids | ANTACID AND ANTIGAS | Infirst Healthcare Inc. | 432d5b4c-a69b-45f9-b7f0-216726a3eead | 2023-12-01 | Warnings | 92RU3N3Y1O |
| Cetaphil Cracked Skin Repair Balm | DIMETHICONE | Galderma Laboratories, L.P. | 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956 | 2023-11-30 | Warnings | 92RU3N3Y1O |
| Cetaphil Cracked Skin Repair | DIMETHICONE | Galderma Laboratories, L.P. | 27d74e0f-8359-4c59-bf7f-acade7f4545c | 2023-11-30 | Warnings | 92RU3N3Y1O |
| Inon Ace | MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE | Sato Pharmaceutical Co., Ltd. | 0af4355f-e160-409d-8471-2de98dbc6f7c | 2023-11-10 | Warnings | 92RU3N3Y1O |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.