Prescription drug · ANDA
Everolimus NDC 0093-7769
Everolimus 10 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7769-24 | 00093776924 | 28 BLISTER PACK in 1 CARTON (0093-7769-24) / 1 TABLET in 1 BLISTER PACK (0093-7769-19)Marketed from Oct 23, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210050
- Marketing start
- Marketing end
- 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 0093-7769_0f7ea770-928b-43b2-8971-849d1d12bbc8SPL ID 0f7ea770-928b-43b2-8971-849d1d12bbc8SPL set ID e3bca36b-29ed-4a2b-a1be-a57b6af805f6RxCUI 845507, 845515, 998189, 1119400UNII 9HW64Q8G6G
- 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
N400093776924followed by a unit qualifier and the quantityPackage 00093-7769-24. 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)
Everolimus 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: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced renal cell carcinoma (RCC) …
Excerpt only. Read the full label for complete information.
About NDC 0093-7769
- What is NDC 0093-7769?
- 0093-7769 is the product NDC for Everolimus, Everolimus 10 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 210050
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 | Teva Pharmaceuticals USA, Inc. | 0093-7766 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7767 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7768 |