What is NDC 60505-3613?

60505-3613 is the product NDC for Varenicline, Varenicline tartrate .5 mg/1 tablet, film coated, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.

Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Varenicline?

56 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Varenicline NDC 60505-3613 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-3613Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-3613Add 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
60505-3613-5	6050536130560505361305	56 TABLET, FILM COATED in 1 BOTTLE (60505-3613-5)Marketed from Jan 30, 2023

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): Varenicline
Generic name (nonproprietary): varenicline
Active ingredients: Varenicline tartrate — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Apotex CorpNDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201962
Marketing start: Jan 30, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 60505-3613_02f0b423-771f-6ac3-405e-b90052c22b04SPL ID 02f0b423-771f-6ac3-405e-b90052c22b04
Pharmacologic class: Cholinergic Receptor Agonist; Partial Cholinergic Nicotinic Agonist

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

N460505361305 followed by a unit qualifier and the quantity

Package 60505-3613-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-3613

What is NDC 60505-3613?: 60505-3613 is the product NDC for Varenicline, Varenicline tartrate .5 mg/1 tablet, film coated, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Varenicline.
What is the active ingredient?: Varenicline tartrate.
Who is the labeler?: Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Varenicline?: 56 other product NDCs are listed under this name. See all Varenicline 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 Varenicline NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Vareniclinevarenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4647	70518-4647-00
Varenicline	Varenicline tartrate .5 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-077	60290-0077-0160290-0077-02
Varenicline	Varenicline tartrate 1 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-078	60290-0078-0160290-0078-0260290-0078-03
varenicline	—	Kit	Umedica Laboratories USA Inc.	60290-095	60290-0095-01
Vareniclinevarenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-893	60687-0893-21
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-417	59651-0417-56
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-418	59651-0418-5559651-0418-56
Varenicline	—	Kit	Aurobindo Pharma Limited	59651-451	59651-0451-53
Vareniclinevarenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-808	10135-0808-56
Vareniclinevarenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-809	10135-0809-56

All 57 Varenicline NDCs

Other NDCs under ANDA 201962

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

FDA NDC Directory listings under ANDA 201962
Product	Strength	Form · route	Labeler	Product NDC
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6446
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6447
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-032
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Apotex Corp	60505-3614
Varenicline	—	KitOral	Apotex Corp	60505-3615
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Apotex Corp	60505-4794
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Apotex Corp	60505-4795
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2218
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2219