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 | A-S Medication Solutions | 3519febc-c9df-4559-b07a-92f8b0c7e770 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Rohto Sun and Sport | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 8bcc8882-b886-4b55-9bc4-d4b92a41358f | 2026-06-19 | Warnings | 3NXW29V3WO |
| Rohto Dual Light Relief | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 1b597f83-d7f1-cf93-e063-6394a90a99f7 | 2026-06-19 | Warnings | 3NXW29V3WO |
| E-Z-GAS II | ANTACID/ANTIFLATULENT | E-Z-EM, INC. | 4e12e1cb-b033-076d-e054-00144ff8d46c | 2026-06-15 | Warnings | 92RU3N3Y1O |
| Mag-Al Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Cardinal Health 107, LLC | 08df7403-9ee3-4a43-a151-c1a6ef7a7549 | 2026-06-10 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 33bee4db-d4aa-4c72-8eeb-46ff374a92a6 | 2026-06-10 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | P & L Development, LLC | f4526eba-e6d0-44de-99ea-4af7a6dba199 | 2026-06-10 | Warnings | 92RU3N3Y1O |
| Medline | DIMETHICONE | Medline Industries, LP | 509ee758-9d53-220c-e063-6394a90a4bd5 | 2026-06-09 | Warnings | 92RU3N3Y1O |
| Tums Chewy Bites with Gas Relief | CALCIUM CARBONATE AND SIMETHICONE | Haleon US Holdings LLC | 6d7be7e4-4bff-4cfd-bbbe-df412ac9db10 | 2026-06-09 | Warnings | 92RU3N3Y1O |
| SIMETHICONE | SIMETHICONE | YYBA | 50250112-933c-ffb1-e063-6394a90aaafb | 2026-06-09 | Warnings | 92RU3N3Y1O |
| Medline | DIMETHICONE | Medline Industries, LP | 3c448cf7-8ca5-c7f7-e063-6294a90a75ff | 2026-06-08 | Warnings | 92RU3N3Y1O |
| tacrolimus | TACROLIMUS | NORTHSTAR RX LLC | 875f4962-557e-4e12-ad7b-cb5fb6f2a65f | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| INFANTS GAS RELIEF | SIMETHICONE | Mollec Inc | 53705dbc-daca-2214-e063-6294a90a1097 | 2026-06-04 | Warnings | 92RU3N3Y1O |
| Childrens Simethicone Drops | CHILDRENS SIMETHICONE DROPS | PAI Holdings, LLC dba PAI Pharma | 6e26ffbe-4c5b-4689-99bc-88b39ed40a25 | 2026-06-04 | Warnings | 92RU3N3Y1O |
| Quad Wash | DIMETHICONE | Dynarex Corporation | 535dc862-6a18-26c9-e063-6294a90a3d4a | 2026-06-03 | Warnings | 92RU3N3Y1O |
| Rohto Digi-Eye | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE | The Mentholatum Company | 5d6f37b9-b568-4cb6-92de-eb40779f3f8c | 2026-06-03 | Warnings | 3NXW29V3WO |
| Infants Simethicone Drops | INFANTS SIMETHICONE DROPS | PAI Holdings, LLC dba PAI Pharma | 235f458e-c275-4bc1-9c0f-e007c4040649 | 2026-06-03 | Warnings | 92RU3N3Y1O |
| Gas Relief Extra Strength | SIMETHICONE | Care One (Retail Business Services, LLC.) | 5e2b25a0-eddf-4d58-927f-bc72c0a92c88 | 2026-06-02 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID/ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | NuCare Pharmaceuticals, Inc. | 52e75fe4-f04f-31da-e063-6294a90a1e4f | 2026-05-28 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | CVS PHARMACY, INC | 4ff77b4c-9616-4341-9bf8-eca301345a5f | 2026-05-21 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.