Sirolimus NDC 69238-1594

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1594Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1594Add 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
69238-1594-3	69238159403	1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASSMarketed from Oct 25, 2019

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 — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211212
Marketing start: Oct 25, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 69238-1594_864e5959-61c6-44ff-8fe6-7a2550ba0a85SPL ID 864e5959-61c6-44ff-8fe6-7a2550ba0a85SPL set ID a522b5e1-fe51-4eb8-9657-3b1d6af8dfd5RxCUI 314230UNII W36ZG6FT64UPC 0369238159431, 0369238159462
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

N469238159403 followed by a unit qualifier and the quantity

Package 69238-1594-03. 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 Dec 22, 2022. 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: 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 oral solution is an mTOR inhibitor indicated for the treatment of patients with lymphangiole…

Excerpt only. Read the full label for complete information.

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