Prescription drug · ANDA
Sirolimus NDC 55111-654
Sirolimus 2 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-654-01 | 5511106540155111065401 | 100 TABLET in 1 BOTTLE (55111-654-01)Marketed from Oct 27, 2014 | |
| 55111-654-30 | 5511106543055111065430 | 30 TABLET in 1 BOTTLE (55111-654-30)Marketed from Oct 27, 2014 |
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
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201578
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
- Identifiers
- Product ID 55111-654_f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24bSPL ID f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24bSPL set ID 2e6130e5-fa94-dcf8-605c-817bf396e93dRxCUI 349208, 360110UNII W36ZG6FT64UPC 0355111654018
- 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
N455111065401followed by a unit qualifier and the quantityPackage 55111-0654-01. 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 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 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 ). 1.1 Prop…
Excerpt only. Read the full label for complete information.
About NDC 55111-654
- What is NDC 55111-654?
- 55111-654 is the product NDC for Sirolimus, Sirolimus 2 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 201578
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 1 mg/1 | TabletOral | AvPAK | 50268-718 |
| Sirolimus | Sirolimus 1 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-653 |
| Sirolimus | Sirolimus 1 mg/1 | TabletOral | American Health Packaging | 68084-915 |
| Sirolimus | Sirolimus 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3795 |