What is NDC 65841-771?

65841-771 is the product NDC for sirolimus, Sirolimus .5 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 65841. 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 65841-771 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-771Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0771Add 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
65841-771-01	6584107710165841077101	100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01)Marketed from Jan 15, 2014
65841-771-05	6584107710565841077105	500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05)Marketed from Jan 15, 2014
65841-771-06	6584107710665841077106	30 TABLET, FILM COATED in 1 BOTTLE (65841-771-06)Marketed from Jan 15, 2014
65841-771-10	6584107711065841077110	1000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10)Marketed from Jan 15, 2014
65841-771-16	6584107711665841077116	90 TABLET, FILM COATED in 1 BOTTLE (65841-771-16)Marketed from Jan 15, 2014
65841-771-77	6584107717765841077177	10 BLISTER PACK in 1 CARTON (65841-771-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30)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 Lifesciences LimitedNDC labeler code 65841
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 65841-771_7e6e294d-cf29-40e2-91e1-9693fdcd6b6cSPL ID 7e6e294d-cf29-40e2-91e1-9693fdcd6b6cSPL set ID 82562b68-224d-482a-b399-a89b81d5eb31RxCUI 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

N465841077101 followed by a unit qualifier and the quantity

Package 65841-0771-01. 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 27, 2023.

Full label on DailyMed (opens in a new tab)

About NDC 65841-771

What is NDC 65841-771?: 65841-771 is the product NDC for sirolimus, Sirolimus .5 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 65841. 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 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	Zydus Pharmaceuticals USA Inc.	68382-520
sirolimus	Sirolimus .5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4376