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 |
|---|---|---|---|---|---|---|
| Skin Relief | LOTION | Walgreen | fc678e80-e63d-e3fe-e053-6394a90aa7d6 | 2026-05-03 | Warnings | 92RU3N3Y1O |
| Herpecin L | DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE | Focus Consumer Healthcare, LLC | 5b6ed4e9-3e69-c773-e053-2991aa0a7dfe | 2026-05-01 | Warnings | 92RU3N3Y1O |
| mylanta gas | SIMETHICONE | Infirst Healthcare | ce925db4-fe1a-4069-96be-ce86cdd4e79a | 2026-05-01 | Warnings | 92RU3N3Y1O |
| PHAZYME | SIMETHICONE | C.B. Fleet Company, Inc. | 3bb5cc1f-554b-4a4d-b9e9-665e34924b4b | 2026-04-29 | Warnings | 92RU3N3Y1O |
| Extra strength gas relief | SIMETHICONE | KROGER COMPANY | ea1c7b4c-91a1-0c1c-e053-2995a90ab823 | 2026-04-29 | Warnings | 92RU3N3Y1O |
| Mylanta All-Family Multi Symptom Stomach Remedy | CALCIUM CARBONATE, SIMETHICONE | Sportpharm LLC | a70f113d-d5a3-44f5-b223-cd1b0e159e1a | 2026-04-24 | Warnings | 92RU3N3Y1O |
| Childrens Emetrol Multi Symptom Upset Stomach Relief | CHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEF | WellSpring Pharmaceutical Corporation | fe9ccc29-3cca-4666-9bb5-abb41816b3f5 | 2026-04-23 | Warnings | 92RU3N3Y1O |
| Little Remedies Gas Relief Drops | SIMTHICONE | Medtech Products Inc. | 874d3f1d-1e4a-49ab-8285-4d6bf2601d5e | 2026-04-23 | Warnings | 92RU3N3Y1O |
| CareOne Diarrhea and Gas Control | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | American Sales Company | dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3 | 2026-04-21 | Warnings | 92RU3N3Y1O |
| good sense gas relief | SIMETHICONE | Preferred Pharmaceuticals Inc. | 06836246-9058-42af-a8a3-5aec81f4b9cc | 2026-04-20 | Warnings | 92RU3N3Y1O |
| Joint Tonic R II | HARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUM | BioActive Nutritional, Inc. | 77afccf5-4e9c-45a1-8a6a-e686bcf22f16 | 2026-04-17 | Warnings | W4888I119H |
| Gas Relief | SIMETHICONE | Walgreens | 52cceb6b-f2c8-49bf-b5ce-5d1c999a9b60 | 2026-04-17 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Glenmark Pharmaceuticals Inc., USA | c2d2e3a1-f346-4245-b445-6dd44e371180 | 2026-04-15 | Warnings, Adverse reactions | WM0HAQ4WNM |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Rugby Laboratories | bd58baac-5790-455a-9c77-236680992579 | 2026-04-15 | Warnings | 92RU3N3Y1O |
| Gas Relief Extra Strength | SIMETHICONE | Best Choice (Valu Merchandisers Company) | ce18af91-1c60-44b1-aed2-4f54d394e27e | 2026-04-13 | Warnings | 92RU3N3Y1O |
| Exovisse Preservative-Free Artificial Tears | LUBRICANT EYE GEL DROPS | YD BIO USA, INC. | 4f20191a-9124-2525-e063-6294a90a8428 | 2026-04-10 | Warnings | 3NXW29V3WO |
| BEVERLY HILLS MD HYDRARESCUE TREATMENT | DIMETHICONE | Beverly Hills MD, LLC | 4ed33a43-d059-2589-e063-6294a90a30b3 | 2026-04-09 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Safecor Health LLC | 393cd10e-133c-4d6b-b024-270eb82edbb3 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| LensMate Preservative-Free Artificial Tears | LUBRICANT EYE DROPS | YD BIO USA, INC. | 4ebacb2b-9b2d-6bc1-e063-6294a90a3426 | 2026-04-05 | Warnings | 3NXW29V3WO |
| Exovisse Preservative-Free Artificial Tears | LUBRICANT EYE GEL DROPS | YD BIO USA, INC. | 4ebc154b-128b-9dde-e063-6294a90ae00e | 2026-04-05 | Warnings | 3NXW29V3WO |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.