Prescription drug · ANDA
Yulithira (Everolimus) NDC 82249-612
Everolimus 7.5 mg/1 · Tablet · Oral · CivicaScript, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82249-612-30 | 8224906123082249061230 | 30 TABLET in 1 BOTTLE (82249-612-30)Marketed from Jun 11, 2026 |
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)
- Yulithira
- Generic name (nonproprietary)
- everolimus
- Active ingredients
- Everolimus — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CivicaScript, LLCNDC labeler code 82249
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205426
- 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 82249-612_01d9a611-3216-427b-a18a-15366572b3d3SPL ID 01d9a611-3216-427b-a18a-15366572b3d3SPL set ID 5e325efa-8ae6-4dac-b59b-d7c74c73186cRxCUI 845507, 845515, 998189, 1119400, 2745127, 2745129, 2745131, 2745133UNII 9HW64Q8G6GUPC 0382249610302, 0382249611309, 0382249612306, 0382249613303
- 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
N482249061230followed by a unit qualifier and the quantityPackage 82249-0612-30. 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 .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Yulithira tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: Yulithira tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced rena…
Excerpt only. Read the full label for complete information.
About NDC 82249-612
- What is NDC 82249-612?
- 82249-612 is the product NDC for Yulithira (everolimus), Everolimus 7.5 mg/1 tablet, listed with the FDA by CivicaScript, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yulithira (Everolimus).
- What is the active ingredient?
- Everolimus.
- Who is the labeler?
- CivicaScript, LLC, NDC labeler code 82249. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yulithira?
- 3 other product NDCs are listed under this name. See all Yulithira NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Yulithira products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Yulithiraeverolimus | Everolimus 2.5 mg/1 | TabletOral | CivicaScript, LLC | 82249-610 | 82249-0610-30 |
| Yulithiraeverolimus | Everolimus 5 mg/1 | TabletOral | CivicaScript, LLC | 82249-611 | 82249-0611-30 |
| Yulithiraeverolimus | Everolimus 10 mg/1 | TabletOral | CivicaScript, LLC | 82249-613 | 82249-0613-30 |
Other NDCs under ANDA 205426
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 2.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-821 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-822 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-823 |
| Everolimus | Everolimus 10 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-824 |
| Everolimus | Everolimus 2.5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0058 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0059 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0060 |
| Everolimus | Everolimus 10 mg/1 | TabletOral | Natco Pharma Limited | 63850-0061 |
| Yulithiraeverolimus | Everolimus 2.5 mg/1 | TabletOral | CivicaScript, LLC | 82249-610 |
| Yulithiraeverolimus | Everolimus 5 mg/1 | TabletOral | CivicaScript, LLC | 82249-611 |
| Yulithiraeverolimus | Everolimus 10 mg/1 | TabletOral | CivicaScript, LLC | 82249-613 |