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 |
|---|---|---|---|---|---|---|
| Orajel Cold Sore Moisturelock | BENZOCAINE | Church & Dwight Co., Inc. | 3761c7b3-053b-0f50-e054-00144ff88e88 | 2024-11-26 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36 | 2024-11-25 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | f7c40b12-11e4-4b85-afb2-0ea33e4f218c | 2024-11-25 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 346df37d-b0fc-4fa5-8c19-492fed58c239 | 2024-11-25 | Warnings | 92RU3N3Y1O |
| Extra Strength Gas Relief Cherry | SIMETHICONE | Retail Business Services, LLC. | 1e8ed36d-5236-163b-e063-6294a90ad6ec | 2024-11-22 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 0f9639fa-e1d0-460d-bc46-714a01cd9811 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 852cec3b-6564-46b2-afe5-ecef31424237 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Ultra Strength Gas Relief | SIMETHICONE | Walgreen Co. | d33e413d-4add-459f-ba46-c23b49cfcc87 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | Walgreen Co. | d87a20d4-dd1d-4897-9321-f81df2cfbcc7 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Ultra Strength Gas Relief | SIMETHICONE | Walgreen Co. | b14b647f-d729-47df-879d-ca08a30b995e | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Ultra Strength Gas Relief | SIMETHICONE | Wal-Mart Stores Inc | 206d57ec-c854-496e-af53-7d8b2a208d85 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | WALGREEN CO. | 4d523979-e3ae-47e8-9092-00fdffc8bb0b | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | Wal-Mart Stores Inc | 69351cf9-3092-45ca-8b84-83e3737fa8d4 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Simethicone | SIMETHICONE | WALMART INC. | 79a9e0a3-9199-4397-ab29-b8a9c843cdf8 | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Maximum Strength Gas Relief | SIMETHICONE | FOODHOLD U.S.A., LLC | c37def6e-bb10-41ba-8bce-b06c09edbe9f | 2024-11-21 | Warnings | 92RU3N3Y1O |
| Gas-Aid | SIMETHICONE | Leosons Overseas Corp | d271bfcb-bf13-4a97-bc03-f1824826f15a | 2024-11-19 | Warnings | 92RU3N3Y1O |
| Gas-Aid Drops for infants | SIMETHICONE | Leosons Overseas Corp | 06665701-5f1c-4f8f-8775-e0a4a9ef2029 | 2024-11-19 | Warnings | 92RU3N3Y1O |
| TiZO Photoceutical Environmental Skin Protectant | DIMETHICONE | Fallien Cosmeceuticals, LTD | 84a3299d-9b98-492e-a83f-ebd72ec58f8d | 2024-11-14 | Warnings | 92RU3N3Y1O |
| Mag-AL Plus XS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE | PAI Holdings, LLC dba PAI Pharma | db0c47ab-5296-4195-9fa6-2e338b665094 | 2024-11-12 | Warnings | 92RU3N3Y1O |
| ABC Arbonne Baby Care Diaper Rash | DIMETHICONE AND ZINC OXIDE | Arbonne International, LLC | dd1d8198-bb9d-4508-a971-ae3bc624cdd1 | 2024-11-08 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.