Prescription drug · ANDA
Everolimus NDC 63850-0064
Everolimus .75 mg/1 · Tablet · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0064-2 | 63850006402 | 6 BLISTER PACK in 1 CARTON (63850-0064-2) / 10 TABLET in 1 BLISTER PACKMarketed from May 20, 2021 | |
| 63850-0064-6 | 63850006406 | 60 TABLET in 1 BOTTLE (63850-0064-6)Marketed from May 26, 2023 |
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)
- Everolimus
- Generic name (nonproprietary)
- everolimus
- Active ingredients
- Everolimus — .75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Natco Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205432
- 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 63850-0064_111c2e93-390f-40c6-a626-6aa45878a801SPL ID 111c2e93-390f-40c6-a626-6aa45878a801SPL set ID d44998bb-5deb-4ee7-a0a5-979fe3f49557RxCUI 977427, 977434, 977438, 2056895UNII 9HW64Q8G6GUPC 0363850006326, 0363850006234, 0363850006432, 0363850006425, 0363850006333, 0363850006227
- 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
N463850006402followed by a unit qualifier and the quantityPackage 63850-0064-02. 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 is an 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) ( 1.3 ) 1.1 Prophy…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205432
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 |
|---|---|---|---|---|
| Everolimuseverolimus tablets | Everolimus 1 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-985 |
| Everolimus | Everolimus .5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0063 |
| Everolimus | Everolimus .25 mg/1 | TabletOral | Natco Pharma Limited | 63850-0062 |
| Everolimus | Everolimus 1 mg/1 | TabletOral | Natco Pharma Limited | 63850-0107 |
| Everolimuseverolimus tablets | Everolimus .75 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-381 |
| Everolimuseverolimus tablets | Everolimus .25 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-379 |
| Everolimuseverolimus tablets | Everolimus .5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-380 |