What is NDC 72205-099?

72205-099 is the product NDC for sirolimus, Sirolimus 1 mg/mL solution, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

sirolimus NDC 72205-099 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72205-099Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72205-0099Add 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
72205-099-78	7220500997872205009978	1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASSMarketed from Feb 14, 2023

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 — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Novadoz Pharmaceuticals LLCNDC labeler code 72205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216728
Marketing start: Jan 19, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 72205-099_5f3a03d8-3583-4214-baa9-4fe16d2628d2SPL ID 5f3a03d8-3583-4214-baa9-4fe16d2628d2SPL set ID 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5RxCUI 314230UNII W36ZG6FT64UPC 0372205099784
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

N472205009978 followed by a unit qualifier and the quantity

Package 72205-0099-78. 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 Mar 21, 2025. 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 2-4 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 lymphangioleiom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72205-099

What is NDC 72205-099?: 72205-099 is the product NDC for sirolimus, Sirolimus 1 mg/mL solution, listed with the FDA by Novadoz Pharmaceuticals 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?: Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other sirolimus NDCs
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

All 37 sirolimus NDCs

Other NDCs under ANDA 216728

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

FDA NDC Directory listings under ANDA 216728
Product	Strength	Form · route	Labeler	Product NDC
sirolimus	Sirolimus 1 mg/mL	SolutionOral	Bryant Ranch Prepack	72162-2641
sirolimus	Sirolimus 1 mg/mL	SolutionOral	Northstar Rx LLC	72603-409