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 |
|---|---|---|---|---|---|---|
| Tacrolimus | TACROLIMUS | Dr. Reddy's Laboratories Limited | 61dee012-43af-0e9a-3843-9b9b91e022c4 | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| MINTOX MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Proficient Rx LP | b7711b50-c14a-44d6-b647-1f31284f87ea | 2023-11-01 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e811783-cbf6-d0e3-e053-2991aa0ae69f | 2023-10-31 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CVS | 5f880b43-2977-7a2d-e053-2991aa0a024d | 2023-10-31 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CVS PHARMACY | d5661964-9d2c-7a3d-e053-2995a90a86ef | 2023-10-31 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRY | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e94cb90-b616-dcfe-e053-2a91aa0ada72 | 2023-10-31 | Warnings | 92RU3N3Y1O |
| GAS RELIEF | SIMETHICONE | STRATEGIC SOURCING SERVICES LLC | ff1fd97c-af4f-dffb-e053-6294a90a2039 | 2023-10-26 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Proficient Rx LP | 20d1c12a-bf4b-4467-93a0-ee8b892abea9 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 1P9D0Z171K 92RU3N3Y1O |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 1P9D0Z171K 92RU3N3Y1O |
| Anubis Barcelona Vital Line | HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES | ANUBIS COSMETICS SL | ebe024f7-7c45-ad60-e053-2995a90a45d6 | 2023-09-01 | Warnings | 1P9D0Z171K |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.