What is NDC 60505-6197?

60505-6197 is the product NDC for Sirolimus, Sirolimus 1 mg/mL solution, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.

Apotex Corp, NDC labeler code 60505. 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 60505-6197 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-6197Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-6197Add 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
60505-6197-2	6050561970260505619702	1 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASSMarketed from May 20, 2020

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: Apotex CorpNDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211406
Marketing start: May 20, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 60505-6197_cbf93a5b-f0a1-f8b1-6373-19cca65aa9f3SPL ID cbf93a5b-f0a1-f8b1-6373-19cca65aa9f3
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

N460505619702 followed by a unit qualifier and the quantity

Package 60505-6197-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-6197

What is NDC 60505-6197?: 60505-6197 is the product NDC for Sirolimus, Sirolimus 1 mg/mL solution, listed with the FDA by Apotex Corp. 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?: Apotex Corp, NDC labeler code 60505. 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