Prescription drug · ANDA
Sirolimus NDC 31722-316
Sirolimus 1 mg/mL · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-316-31 | 31722031631 | 1 CARTON in 1 KIT (31722-316-31) / 1 BOTTLE, GLASS in 1 CARTON (31722-316-60) / 60 mL in 1 BOTTLE, GLASSMarketed from Sep 16, 2024 |
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)
- Sirolimus
- Generic name (nonproprietary)
- sirolimus
- Active ingredients
- Sirolimus — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215080
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-316_27e377c2-1e6a-d4e2-e063-6394a90a2812SPL ID 27e377c2-1e6a-d4e2-e063-6394a90a2812SPL set ID 80269e86-3b04-44d0-9bff-7e7129e8ccb3RxCUI 314230UNII W36ZG6FT64UPC 0331722316606
- 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
N431722031631followed by a unit qualifier and the quantityPackage 31722-0316-31. 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 oral solution is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation ( 1.1 ). o 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 oral solution is an mTOR inhibitor indicated for the treatment of patients with lymp…
Excerpt only. Read the full label for complete information.