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 |
|---|---|---|---|---|---|---|
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Chain Drug Marketing Association | 9f410b3a-5579-4fae-84b1-5cd35563451e | 2023-11-06 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Chain Drug Marketing Association | 60de23d0-6e75-3b97-e053-2a91aa0aea5e | 2023-11-06 | Warnings | 92RU3N3Y1O |
| Skin-lube | PETROLATUM, DIMETHICONE | The Hygenic Company, LLC. | d1005dec-04f6-3f88-e053-2a95a90ad9cb | 2023-11-05 | Warnings | 92RU3N3Y1O |
| MINTOX MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | MAJOR Pharmaceuticals Inc. | 536b143d-a1d7-4972-a90b-248e41937070 | 2023-11-02 | Warnings | 92RU3N3Y1O |
| ALMACONE DOUBLE STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | RUGBY LABORATORIES | 25f22cff-2864-4853-a7f8-8edd9f8f3c29 | 2023-11-02 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e8215a4-0136-bfdd-e053-2991aa0a5ddf | 2023-11-01 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e82a4f4-c7da-09cb-e053-2a91aa0abf5b | 2023-11-01 | Warnings | 92RU3N3Y1O |
| INFANTS GAS RELIEF | SIMETHICONE | Geri-Care Pharmaceuticals, Corp | 5e08709c-846a-7f13-e053-2991aa0a09a6 | 2023-11-01 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | WAL-MART STORES, INC. | 7cc2ad32-fdff-0772-e053-2a91aa0aad9e | 2023-11-01 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH ANTACID CHERRY | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | WAL-MART STORES, INC. | 7cc2771e-abd7-4120-e053-2a91aa0a8af0 | 2023-11-01 | Warnings | 92RU3N3Y1O |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.