Prescription drug · ANDA
sirolimus NDC 70518-4376
Sirolimus .5 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4376-0 | 70518437600 | 100 POUCH in 1 BOX (70518-4376-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4376-1)Marketed from Jun 28, 2025 |
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)
- sirolimus
- Generic name (nonproprietary)
- sirolimus
- Active ingredients
- Sirolimus — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201676
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4376_38c957b7-27e3-d35c-e063-6294a90aa511SPL ID 38c957b7-27e3-d35c-e063-6294a90aa511SPL set ID 09f24e7a-0bea-4e02-b557-c60eb842d41aRxCUI 905158UNII W36ZG6FT64
- 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
N470518437600followed by a unit qualifier and the quantityPackage 70518-4376-00. 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)
Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 months to 4 months after transplantation ( 1.1 ). Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients ( 1.1 , 1.2 , 14.3 ). Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis ( 1.3 ). 1…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201676
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 |
|---|---|---|---|---|
| sirolimus | Sirolimus 2 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-352 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-351 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-520 |
| sirolimus | Sirolimus 2 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-773 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-771 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-772 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-902 |