sirolimus NDC 68382-520

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-520Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0520Add 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
68382-520-01	68382052001	100 TABLET, FILM COATED in 1 BOTTLE (68382-520-01)Marketed from Jan 15, 2014
68382-520-05	68382052005	500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)Marketed from Jan 15, 2014
68382-520-06	68382052006	30 TABLET, FILM COATED in 1 BOTTLE (68382-520-06)Marketed from Jan 15, 2014
68382-520-10	68382052010	1000 TABLET, FILM COATED in 1 BOTTLE (68382-520-10)Marketed from Jan 15, 2014
68382-520-16	68382052016	90 TABLET, FILM COATED in 1 BOTTLE (68382-520-16)Marketed from Jan 15, 2014
68382-520-77	68382052077	10 BLISTER PACK in 1 CARTON (68382-520-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-520-30)Marketed from Jan 15, 2014

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 — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201676
Marketing start: Jan 15, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 68382-520_f54f3f24-5d0f-44a1-a4ca-03950954826fSPL ID f54f3f24-5d0f-44a1-a4ca-03950954826fSPL set ID ec473170-47f1-4a5c-b4d9-ac36406ed241RxCUI 349208, 360110, 905158UNII W36ZG6FT64UPC 0368382352019, 0368382351012
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

N468382052001 followed by a unit qualifier and the quantity

Package 68382-0520-01. 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 20, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Sirolimus 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 months 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 is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis ( 1.3 ). 1…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201676

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

FDA NDC Directory listings under ANDA 201676
Product	Strength	Form · route	Labeler	Product NDC
sirolimus	Sirolimus .5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4376
sirolimus	Sirolimus 2 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-352
sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-351
sirolimus	Sirolimus 2 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-773
sirolimus	Sirolimus .5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-771
sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-772
sirolimus	Sirolimus .5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-902