Prescription drug · NDA
Envarsus XR (Tacrolimus) NDC 68992-3075
Tacrolimus .75 mg/1 · Tablet, Extended release · Oral · Veloxis Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68992-3075-1 | 6899230750168992307501 | 1 POUCH in 1 CARTON (68992-3075-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 1, 2015 | |
| 68992-3075-3 | 6899230750368992307503 | 1 POUCH in 1 CARTON (68992-3075-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Sep 1, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Envarsus XRSuffix: XR
- Generic name (nonproprietary)
- tacrolimus
- Active ingredients
- Tacrolimus — .75 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Veloxis Pharmaceuticals, IncNDC labeler code 68992
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206406
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 68992-3075_163c129d-f4e2-484d-af96-c265c9a5e38cSPL ID 163c129d-f4e2-484d-af96-c265c9a5e38cSPL set ID de2315b0-6344-43ac-9aea-3e3b68d828e7RxCUI 1664434, 1664440, 1664456, 1664458, 1664461, 1664463UNII WM0HAQ4WNMUPC 0368992304033, 0368992301032, 0368992307539, 0368992301018, 0368992307515
- Pharmacologic class
- Calcineurin Inhibitor Immunosuppressant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468992307501followed by a unit qualifier and the quantityPackage 68992-3075-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants ( 1.1 ) The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in De Novo Kidney Transplant Patients ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants [see Clinical Studies (14.1) ]. 1.2 Prophylaxis of Organ Rejection in Stable Kidney Transplant Patients Converting …
Excerpt only. Read the full label for complete information.
About NDC 68992-3075
- What is NDC 68992-3075?
- 68992-3075 is the product NDC for Envarsus XR (tacrolimus), Tacrolimus .75 mg/1 tablet, extended release, listed with the FDA by Veloxis Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Envarsus XR (Tacrolimus).
- What is the active ingredient?
- Tacrolimus.
- Who is the labeler?
- Veloxis Pharmaceuticals, Inc, NDC labeler code 68992. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Envarsus XR?
- 2 other product NDCs are listed under this name. See all Envarsus XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Envarsus XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Envarsus XRtacrolimus | Tacrolimus 1 mg/1 | Tablet, Extended releaseOral | Veloxis Pharmaceuticals, Inc | 68992-3010 | 68992-3010-0168992-3010-03 |
| Envarsus XRtacrolimus | Tacrolimus 4 mg/1 | Tablet, Extended releaseOral | Veloxis Pharmaceuticals, Inc | 68992-3040 | 68992-3040-0168992-3040-03 |
Other NDCs under NDA 206406
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Envarsus XRtacrolimus | Tacrolimus 1 mg/1 | Tablet, Extended releaseOral | Veloxis Pharmaceuticals, Inc | 68992-3010 |
| Envarsus XRtacrolimus | Tacrolimus 4 mg/1 | Tablet, Extended releaseOral | Veloxis Pharmaceuticals, Inc | 68992-3040 |