Prescription drug · ANDA
Everolimus NDC 70954-774
Everolimus 3 mg/1 · Tablet, For suspension · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-774-20 | 70954077420 | 28 BLISTER PACK in 1 CARTON (70954-774-20) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70954-774-10)Marketed from Oct 10, 2025 |
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 — 3 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220597
- 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 70954-774_ed7f01b0-3660-4785-a057-a32eea78d64bSPL ID ed7f01b0-3660-4785-a057-a32eea78d64b
- 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
N470954077420followed by a unit qualifier and the quantityPackage 70954-0774-20. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70954-774
- What is NDC 70954-774?
- 70954-774 is the product NDC for Everolimus, Everolimus 3 mg/1 tablet, for suspension, listed with the FDA by ANI Pharmaceuticals, 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?
- 67 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 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 7.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-032 | 82293-0032-1082293-0032-2182293-0032-31 |
| 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 220597
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 mg/1 | Tablet, For suspensionOral | ANI Pharmaceuticals, Inc. | 70954-773 |
| Everolimus | Everolimus 5 mg/1 | Tablet, For suspensionOral | ANI Pharmaceuticals, Inc. | 70954-775 |