Prescription drug · ANDA
Everolimus NDC 67877-721
Everolimus 1 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-721-31 | 67877072131 | 6 BLISTER PACK in 1 CARTON (67877-721-31) / 10 TABLET in 1 BLISTER PACK (67877-721-33)Marketed from Nov 27, 2021 | |
| 67877-721-60 | 67877072160 | 60 TABLET in 1 BOTTLE (67877-721-60)Marketed from Nov 27, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Everolimus
- Generic name (nonproprietary)
- everolimus
- Active ingredients
- Everolimus — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214138
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-721_33247fe5-9b47-4513-93fe-fc65e4c1b63fSPL ID 33247fe5-9b47-4513-93fe-fc65e4c1b63fSPL set ID 2693c497-a70b-4d00-b6db-602c872e5bedRxCUI 977427, 977434, 977438, 2056895UNII 9HW64Q8G6GUPC 0367877721316, 0367877720319, 0367877719313, 0367877718316
- Pharmacologic class
- Kinase Inhibitor; mTOR 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
N467877072131followed by a unit qualifier and the quantityPackage 67877-0721-31. 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)
Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: • Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1 ) • Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2 , 5.5 ) Limitations of Use: Safety and efficacy have not been established in the following: • Kidney transplant patients at high immunologic risk ( 1.3 ) • Recipients of transplanted organs other than kidney or liver ( 1.3 , 5.7 ) • Pediatric patients (less than 18 years) ( 1.…
Excerpt only. Read the full label for complete information.
About NDC 67877-721
- What is NDC 67877-721?
- 67877-721 is the product NDC for Everolimus, Everolimus 1 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Everolimus.
- What is the active ingredient?
- Everolimus.
- Who is the labeler?
- Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Everolimus?
- 68 other product NDCs are listed under this name. See all Everolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Everolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Everolimus | Everolimus .25 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-003 | 72319-0003-0272319-0003-60 |
| Everolimus | Everolimus .5 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-015 | 72319-0015-0272319-0015-60 |
| Everolimus | Everolimus .75 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-016 | 72319-0016-0272319-0016-60 |
| Everolimus | Everolimus 1 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-017 | 72319-0017-0272319-0017-60 |
| everolimus | Everolimus 7.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-032 | 82293-0032-1082293-0032-2182293-0032-31 |
| everolimus | Everolimus 2.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-030 | 82293-0030-1082293-0030-2182293-0030-31 |
| everolimus | Everolimus 5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-031 | 82293-0031-1082293-0031-2182293-0031-31 |
| everolimus | Everolimus 10 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-033 | 82293-0033-1082293-0033-2182293-0033-31 |
| everolimus | Everolimus .25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-931 | 59651-0931-60 |
| everolimus | Everolimus .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-932 | 59651-0932-60 |
Other NDCs under ANDA 214138
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 |
|---|---|---|---|---|
| Everolimus | Everolimus .25 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-718 |
| Everolimus | Everolimus .5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-719 |
| Everolimus | Everolimus .75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-720 |