What is NDC 59762-1003?

59762-1003 is the product NDC for Sirolimus, Sirolimus 2 mg/1 tablet, sugar coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 59762. 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 59762-1003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59762-1003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59762-1003Add 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
59762-1003-1	5976210030159762100301	100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1003-1)Marketed from Oct 27, 2014

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 — 2 mg/1
Dosage form: Tablet, Sugar coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 59762
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021110
Marketing start: Oct 27, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 59762-1003_8f2761f9-9bc3-47c3-8093-6375a39d1034SPL ID 8f2761f9-9bc3-47c3-8093-6375a39d1034SPL set ID 5908cd1a-fc5a-462f-99ed-1d8983e253c9RxCUI 349208, 360110, 905158UNII 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

N459762100301 followed by a unit qualifier and the quantity

Package 59762-1003-01. 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 Mar 26, 2026. 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 2–4 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 ). 1.1 P…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59762-1003

What is NDC 59762-1003?: 59762-1003 is the product NDC for Sirolimus, Sirolimus 2 mg/1 tablet, sugar coated, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 59762. 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 NDA 021110

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

FDA NDC Directory listings under NDA 021110
Product	Strength	Form · route	Labeler	Product NDC
Sirolimus	Sirolimus .5 mg/1	Tablet, Sugar coatedOral	Mylan Pharmaceuticals Inc.	59762-1001
Sirolimus	Sirolimus 1 mg/1	Tablet, Sugar coatedOral	Mylan Pharmaceuticals Inc.	59762-1002