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 |
|---|---|---|---|---|---|---|
| Foster and Thrive infants Gas relief | SIMETHICONE | Strategic Sourcing Services LLC | 824c9dff-0a26-4710-a25b-39df631d6fa6 | 2024-12-13 | Warnings | 92RU3N3Y1O |
| Gas-X Extra Strength | SIMETHICONE | Haleon US Holdings LLC | 7ce312ca-542b-4bc0-97b5-f65279e1e84c | 2024-12-13 | Warnings | 92RU3N3Y1O |
| Mylanta Maximum Strength Classic Flavor | ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 56853b20-a2aa-4b19-a428-3dde232114c6 | 2024-12-11 | Warnings | 92RU3N3Y1O |
| Mylanta New Tonight Soothing Honey Chamomile | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 123f3005-a0a0-4970-94f1-f6d04741078b | 2024-12-11 | Warnings | 92RU3N3Y1O |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | NuCare Pharmaceuticals, Inc. | fd160cfd-9ad4-81c7-e053-6394a90a33f6 | 2024-12-11 | Warnings | 92RU3N3Y1O |
| Blistex Medicated | DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL | Blistex Inc. | e95439d3-f12b-4c1c-999a-79f2ddba4cfb | 2024-12-11 | Warnings | 92RU3N3Y1O |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | 74823298-d24a-4ffe-8446-1661305372b2 | 2024-12-11 | Warnings | 92RU3N3Y1O |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | ce2edc57-e550-4aa9-bbfe-37933913c9eb | 2024-12-11 | Warnings | 92RU3N3Y1O |
| Antacid Antigas | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | c8173d42-f900-4527-aa56-472d1177a9bc | 2024-12-11 | Warnings | 92RU3N3Y1O |
| Blistex Five Star Lip Protection Broad Spectrum | HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE | Blistex Inc. | 47b57317-7df5-442e-a3a4-1d44fe278ac6 | 2024-12-10 | Warnings | 92RU3N3Y1O |
| Deep Renewal Broad Spectrum | DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE | Blistex Inc | 11c0e084-dc40-4969-a176-3af4116d6f27 | 2024-12-10 | Warnings | 92RU3N3Y1O |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Geri-Care Pharmaceuticals, Corp | b8712a98-30b7-4154-a5bf-0095ef901412 | 2024-12-09 | Warnings | 92RU3N3Y1O |
| MAXIMUM STRENGTH Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Geri-Care Pharmaceuticals, Corp | 25c93d2a-3c48-ca3a-e063-6294a90a312e | 2024-12-09 | Warnings | 92RU3N3Y1O |
| BOA VIDA Recovery Creme | DIMETHICONE | Central Solutions Inc | bfa07058-7a20-4b9f-bad1-4b9fb5c037e0 | 2024-12-09 | Warnings | 92RU3N3Y1O |
| BOA VIDA Canopy | DIMETHICONE | Central Solutions Inc | 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf | 2024-12-09 | Warnings | 92RU3N3Y1O |
| BOA VIDA Cleansing | DIMETHICONE | Central Solutions Inc | 0b456b20-ab06-4adf-b5f0-1693d33979df | 2024-12-09 | Warnings | 92RU3N3Y1O |
| Tacrolimus | TACROLIMUS | Panacea Biotec Limited | bd9fea26-0236-d437-c7df-4b7636210875 | 2024-12-09 | Boxed warning, Warnings, Adverse reactions | WM0HAQ4WNM |
| SOOTHE Sensitive Skin Treatment | ALLANTOIN, DIMETHICONE | Rodan & Fields | 2bd8cac4-5f40-4d04-91f2-3ea8a138033b | 2024-12-09 | Warnings | 92RU3N3Y1O |
| REGULAR STRENGTH ANTACID MINT | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CVS | 3cdfa932-6a20-2a82-e054-00144ff88e88 | 2024-12-05 | Warnings | 92RU3N3Y1O |
| Readyflush Protect Wipes Fragrance Free | DIMETHICONE | Medline Industries, LP | 743d21bd-c40a-4415-ad97-0d8aa99a8af7 | 2024-12-02 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.