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 |
|---|---|---|---|---|---|---|
| Anubis Barcelona Protective Line | ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE | ANUBIS COSMETICS SL | ec83846f-11c0-8f59-e053-2995a90ab9d2 | 2023-09-01 | Warnings | 1P9D0Z171K 92RU3N3Y1O |
| Anubis Barcelona Regul Oil | CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE | ANUBIS COSMETICS SL | eb68c3ab-7835-1a1c-e053-2995a90a0d66 | 2023-09-01 | Warnings | 1P9D0Z171K |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | 1P9D0Z171K |
| Prograf | TACROLIMUS | Astellas Pharma US, Inc. | 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b | 2023-08-25 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| INFANT GAS RELIEF | SIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 7d3c3cc6-b0a2-620d-e053-2a91aa0a159b | 2023-07-18 | Warnings | 92RU3N3Y1O |
| GERI-LANTA ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | A-S Medication Solutions | 3b13e528-b2e8-46c1-a3f9-e2e07f637cb8 | 2023-02-06 | Warnings | 92RU3N3Y1O |
| Loperamide Hydrochloride and Simethicone | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | Camber Consumer Care Inc | e2a4af66-1d05-408c-9f11-f2a9f325d75c | 2022-09-12 | Warnings | 92RU3N3Y1O |
| Loperamide HCl and Simethicone | LOPERAMIDE HCL AND SIMETHICONE | Ohm Laboratories Inc. | 06f99f59-e702-49f1-bb1d-e7cf58c54c30 | 2022-08-30 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Padagis Israel Pharmaceuticals Ltd | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 2021-11-15 | Warnings, Adverse reactions | WM0HAQ4WNM |
| Gas Relief | SIMETHICONE | Allegiant Health | ae98861e-6a26-4e0e-a66a-b2738d3cbddd | 2021-09-24 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | Allegiant Health | 4c79535c-4372-4fd4-a91a-d93617cd581b | 2021-09-24 | Warnings | 92RU3N3Y1O |
| Loperamide Hydrochloride, Simethicone | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | Guardian Drug Company | 1b79204e-8a99-455b-84d6-f381fd7d1135 | 2021-06-01 | Warnings | 92RU3N3Y1O |
| Anti-Gas | SIMETHICONE | Allegiant Health | 7731bd63-667e-4fed-b446-92a4a83b66d6 | 2020-11-03 | Warnings | 92RU3N3Y1O |
| Anti-Gas | SIMETHICONE | Marc Glassman, Inc. | e99f2041-2543-4331-9f54-9eea179f94d2 | 2020-10-06 | Warnings | 92RU3N3Y1O |
| Oatmeal Skin Relief Calming . 8oz | DIMETHICONE | Rejoice International Inc. | 8384dc52-ba36-da3d-e053-2a91aa0a4f40 | 2019-03-07 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | Advance Pharmaceutical Inc. | 531b9850-c93e-4a0c-bd1c-7da33d752d80 | 2018-12-17 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Advance Pharmaceutical Inc. | e11928e8-b9db-43c5-972b-33b325090dfc | 2018-12-17 | Warnings | 92RU3N3Y1O |
| Heartburn Plus Gas Relief Chewable Multi Symptom | CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE | WALGREEN CO. | 2c02e195-9c17-4ddc-80c2-52e51ae9eba0 | 2018-01-01 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Richmond Pharmaceuticals, Inc. | f4be1c0d-01fc-4681-9068-905ed3184534 | 2017-10-30 | Warnings | 92RU3N3Y1O |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE | CVS | d97cd600-6fc4-4d39-9e41-344e44646506 | 2017-08-09 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.