Sirolimus NDC 67877-746

NDC codes

FDA NDC Directory

Product NDC (as listed)67877-746Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67877-0746Add 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
67877-746-01	67877074601	100 TABLET, FILM COATED in 1 BOTTLE (67877-746-01)Marketed from Mar 13, 2021
67877-746-05	67877074605	500 TABLET, FILM COATED in 1 BOTTLE (67877-746-05)Marketed from Mar 13, 2021
67877-746-30	67877074630	30 TABLET, FILM COATED in 1 BOTTLE (67877-746-30)Marketed from Mar 13, 2021
67877-746-38	67877074638	100 BLISTER PACK in 1 CARTON (67877-746-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-746-33)Marketed from Mar 13, 2021

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: Ascend Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214753
Marketing start: Mar 13, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 67877-746_b6349068-caf8-4f40-959d-cb9f1b8dd2beSPL ID b6349068-caf8-4f40-959d-cb9f1b8dd2beSPL set ID cdc49844-3e77-41d3-8287-b16d0c4742c5RxCUI 349208, 360110, 905158UNII W36ZG6FT64UPC 0367877746012
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

N467877074601 followed by a unit qualifier and the quantity

Package 67877-0746-01. 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 Sep 18, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

• Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o 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 ). o 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 tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatos…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214753

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

FDA NDC Directory listings under ANDA 214753
Product	Strength	Form · route	Labeler	Product NDC
Sirolimus	Sirolimus .5 mg/1	TabletOral	REMEDYREPACK INC.	70518-3546
Sirolimus	Sirolimus 2 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-748
Sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7248
Sirolimus	Sirolimus 1 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-747