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.
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|---|---|---|---|---|---|---|
| Cracked Heel Repair Balm | DIMETHICONE | Delta Brands Inc. | 42b7c9f8-0557-8e33-e063-6394a90a5919 | 2026-01-30 | Warnings | 92RU3N3Y1O |
| Readybath TPC Total Perineal Care | DIMETHICONE | Medline Industries, Inc. | 43a3f0f7-f76f-434d-a21f-7eaa3638913d | 2026-01-30 | Warnings | 92RU3N3Y1O |
| TheraCare Diabetic Foot Cream | DIMETHICONE, PETROLATUM | Veridian Healthcare | 49132a75-4a16-cede-e063-6294a90a6217 | 2026-01-29 | Warnings | 92RU3N3Y1O |
| DAILY MOISTURIZING | DIMETHICONE LOTION | Aldi, Inc | 4ad18f4a-e148-4bf5-a04b-4168fa48eeb2 | 2026-01-29 | Warnings, Adverse reactions | 92RU3N3Y1O |
| TriDerma Stubborn Diaper Rash Relief | ALLANTOIN, DIMETHICONE | Genuine Virgin Aloe Corporation | f8f3ae0b-aa55-4c2f-8823-54268524917b | 2026-01-28 | Warnings | 92RU3N3Y1O |
| TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER | ALLANTOIN, DIMETHICONE | Genuine Virgin Aloe Corporation | 3209f075-90bf-4141-b5f3-8175c1ee6ba0 | 2026-01-28 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 1bf44a84-14fd-4f80-ad8a-99b1431d631f | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Herpecin L | ZINC OXIDE, DIMETHICONE | Focus Consumer Healthcare, LLC | 488a29c3-dd97-af1a-e063-6394a90aba7f | 2026-01-26 | Warnings | 92RU3N3Y1O |
| tacrolimus | TACROLIMUS | Glenmark Pharmaceuticals Inc., USA | 4b310c6b-e035-4e44-9573-4001d58b2ad5 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| WORKMANS FRIEND SUPERIOR BARRIER SKIN | DIMETHICONE | SolvChem, Inc. | da12ac2c-1af9-47b1-aa5f-77acb48535ba | 2026-01-16 | Warnings | 92RU3N3Y1O |
| Walgreen Liquid Antacid | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE | WALGREENS CO. | 19c0d031-ee2b-47a9-9f1a-b751a61d37e5 | 2026-01-16 | Warnings | 92RU3N3Y1O |
| INCONTINENCE CARE WIPE | DIMETHICONE | Cardinal Health 200, Inc. | 1ac34c94-9e3b-45f2-ba19-a07dcd3941dd | 2026-01-15 | Warnings | 92RU3N3Y1O |
| GG XEROZINE 15 | SKIN PROTECTANT | GERI-GENTLE CORPORATION | e6881c6d-f584-26d0-e053-2995a90a3873 | 2026-01-14 | Warnings | 92RU3N3Y1O |
| ASTAGRAF XL | TACROLIMUS EXTENDED-RELEASE CAPSULES | Astellas Pharma US, Inc. | 550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| Rolaids Advanced Antacid Anti-gas Wild Berry | CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONE | Chattem, Inc. | 07649a83-0123-4bb5-b130-3067c7d052c5 | 2026-01-14 | Warnings | 92RU3N3Y1O |
| Water Drench Hyaluronic Healing Balm | DIMETHICONE | Peter Thomas Roth Labs, LLC | 3f789176-1d80-d146-e063-6294a90a948a | 2026-01-13 | Warnings | 92RU3N3Y1O |
| Daily VLotion | DIMETHICONE | Kindra | 1cc4b804-6483-68fd-e063-6294a90a38e4 | 2026-01-08 | Warnings | 92RU3N3Y1O |
| V Relief Serum | DIMETHICONE | Kindra | 1cd8a9e9-ac88-1799-e063-6294a90a3278 | 2026-01-08 | Warnings | 92RU3N3Y1O |
| QUITA COLICOS Gas RELIEF Drops | SIMETHICONE | DLC Laboratories, Inc. | d4b0fa36-5925-4a6f-b3c9-0c785503976f | 2026-01-07 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | BPI Labs LLC | 3e8bc65e-8048-4073-8e45-570330603000 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.