Sirolimus NDC 70518-3546

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3546Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3546Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
70518-3546-0	70518354600	100 POUCH in 1 BOX (70518-3546-0) / 1 TABLET in 1 POUCH (70518-3546-1)Marketed from Sep 30, 2022

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
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214753
Marketing start: Sep 30, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 70518-3546_3ab2126f-36af-6239-e063-6394a90a38eaSPL ID 3ab2126f-36af-6239-e063-6394a90a38eaSPL set ID 74549ff2-74dc-449d-9a01-087260f9f8beRxCUI 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

N470518354600 followed by a unit qualifier and the quantity

Package 70518-3546-00. 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 Jul 24, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

• Sirolimus tablet 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 2-4 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 tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatos…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214753

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214753
Product	Strength	Form · route	Labeler	Product NDC
Sirolimus	Sirolimus 2 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-748
Sirolimus	Sirolimus .5 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-746
Sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7248
Sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-747