Prescription drug · ANDA
sirolimus NDC 68462-684
Sirolimus 2 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-684-01 | 68462068401 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-684-01)Marketed from Oct 16, 2020 |
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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208691
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-684_72132b30-e98c-4f0c-9fb7-ecb63ba18224SPL ID 72132b30-e98c-4f0c-9fb7-ecb63ba18224SPL set ID 57fb4d90-3ccb-4a69-af1e-53be83f7a504RxCUI 349208, 360110, 905158UNII W36ZG6FT64UPC 0368462682012
- 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
N468462068401followed by a unit qualifier and the quantityPackage 68462-0684-01. 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 tablets are 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 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 ). 1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus tablets are indicated for the p…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208691
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 .5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4449 |
| sirolimus | Sirolimus 2 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-189 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-683 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-187 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-188 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-682 |