What is NDC 68382-520?

68382-520 is the product NDC for sirolimus, Sirolimus .5 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-520 | National Drug Code

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	6838205200168382052001	100 TABLET, FILM COATED in 1 BOTTLE (68382-520-01)Marketed from Jan 15, 2014
68382-520-05	6838205200568382052005	500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)Marketed from Jan 15, 2014
68382-520-06	6838205200668382052006	30 TABLET, FILM COATED in 1 BOTTLE (68382-520-06)Marketed from Jan 15, 2014
68382-520-10	6838205201068382052010	1000 TABLET, FILM COATED in 1 BOTTLE (68382-520-10)Marketed from Jan 15, 2014
68382-520-16	6838205201668382052016	90 TABLET, FILM COATED in 1 BOTTLE (68382-520-16)Marketed from Jan 15, 2014
68382-520-77	6838205207768382052077	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.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201676
Marketing start: Jan 15, 2014
Listing expires: Dec 31, 2027
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)

About NDC 68382-520

What is NDC 68382-520?: 68382-520 is the product NDC for sirolimus, Sirolimus .5 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 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	American Health Packaging	60687-902
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 2 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-773
sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-351
sirolimus	Sirolimus 2 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-352
sirolimus	Sirolimus .5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4376