Prescription drug · ANDA
sirolimus NDC 16714-189
Sirolimus 2 mg/1 · Tablet, Film coated · Oral · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-189-01 | 1671401890116714018901 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01)Marketed from Oct 18, 2021 |
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
- Labeler
- NORTHSTAR RX LLCNDC labeler code 16714
- 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 16714-189_433f1406-4cb9-4ae3-bdb9-2ff4c9011e5eSPL ID 433f1406-4cb9-4ae3-bdb9-2ff4c9011e5eSPL set ID ad39eb60-1fa0-4722-8ba1-523194921c2aRxCUI 349208, 360110, 905158UNII W36ZG6FT64UPC 0316714189017, 0316714188010, 0316714187013
- 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
N416714018901followed by a unit qualifier and the quantityPackage 16714-0189-01. 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 ). • Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomy…
Excerpt only. Read the full label for complete information.
About NDC 16714-189
- What is NDC 16714-189?
- 16714-189 is the product NDC for sirolimus, Sirolimus 2 mg/1 tablet, film coated, listed with the FDA by NORTHSTAR RX LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- sirolimus.
- What is the active ingredient?
- Sirolimus.
- Who is the labeler?
- NORTHSTAR RX LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for sirolimus?
- 36 other product NDCs are listed under this name. See all sirolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other sirolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-902 | 60687-0902-21 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4449 | 70518-4449-00 |
| Sirolimus | Sirolimus 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 16571-806 | 16571-0806-06 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4376 | 70518-4376-00 |
| Sirolimus | Sirolimus 1 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-316 | 31722-0316-31 |
| Sirolimus | Sirolimus 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3795 | 70518-3795-00 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-772 | 65841-0772-0165841-0772-77 |
| sirolimus | Sirolimus 2 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-773 | 65841-0773-0165841-0773-77 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-351 | 68382-0351-0168382-0351-77 |
| sirolimus | Sirolimus 2 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-352 | 68382-0352-0168382-0352-77 |
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 | 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 |
| sirolimus | Sirolimus 1 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-683 |
| sirolimus | Sirolimus 2 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-684 |
| sirolimus | Sirolimus .5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4449 |