NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2641Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2641Add 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 NDC11-digit (billing)PackageCopy
72162-2641-672162264106721622641061 BOTTLE, GLASS in 1 CARTON (72162-2641-6) / 60 mL in 1 BOTTLE, GLASSMarketed from May 6, 2026

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
Bryant Ranch PrepackNDC labeler code 72162
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216728
Marketing start
Listing expires
Other FDA classes
Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers
Product ID 72162-2641_71b9e046-12b4-4224-ab7a-ae65b34b5c1cSPL ID 71b9e046-12b4-4224-ab7a-ae65b34b5c1cSPL set ID f9843d49-0e16-4427-9cea-9f66f32b97f7RxCUI 314230UNII 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

N472162264106 followed by a unit qualifier and the quantity

Package 72162-2641-06. 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 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 72162-2641

What is NDC 72162-2641?
72162-2641 is the product NDC for sirolimus, Sirolimus 1 mg/mL solution, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 72162. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
sirolimusSirolimus .5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-90260687-0902-21
sirolimusSirolimus .5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-444970518-4449-00
SirolimusSirolimus 1 mg/mLSolutionOralRising Pharma Holdings, Inc.16571-80616571-0806-06
sirolimusSirolimus .5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-437670518-4376-00
SirolimusSirolimus 1 mg/mLSolutionOralCamber Pharmaceuticals, Inc.31722-31631722-0316-31
SirolimusSirolimus 1 mg/1TabletOralREMEDYREPACK INC.70518-379570518-3795-00
sirolimusSirolimus 1 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-77265841-0772-0165841-0772-77
sirolimusSirolimus 2 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-77365841-0773-0165841-0773-77
sirolimusSirolimus 1 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-35168382-0351-0168382-0351-77
sirolimusSirolimus 2 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-35268382-0352-0168382-0352-77

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
ProductStrengthForm · routeLabelerProduct NDC
sirolimusSirolimus 1 mg/mLSolutionOralNovadoz Pharmaceuticals LLC72205-099
sirolimusSirolimus 1 mg/mLSolutionOralNorthstar Rx LLC72603-409

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