What is NDC 60290-095?

60290-095 is the product NDC for varenicline kit, listed with the FDA by Umedica Laboratories USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Umedica Laboratories USA Inc., NDC labeler code 60290. 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 60290-095 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60290-095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60290-0095Add 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
60290-095-01	6029000950160290009501	1 KIT in 1 BLISTER PACK (60290-095-01) * 11 TABLET in 1 BLISTER PACK * 42 TABLET in 1 BLISTER PACKMarketed from Apr 17, 2026

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): varenicline
Generic name (nonproprietary): varenicline
Dosage form: Kit
Labeler: Umedica Laboratories USA Inc.NDC labeler code 60290
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218985
Marketing start: Jan 9, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 60290-095_5bf974b2-49dd-528f-e063-6394a90abacaSPL ID 5bf974b2-49dd-528f-e063-6394a90abaca

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N460290009501 followed by a unit qualifier and the quantity

Package 60290-0095-01. 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

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

About NDC 60290-095

What is NDC 60290-095?: 60290-095 is the product NDC for varenicline kit, listed with the FDA by Umedica Laboratories USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: varenicline.
Who is the labeler?: Umedica Laboratories USA Inc., NDC labeler code 60290. 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
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
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-489	33342-0489-19

All 57 varenicline NDCs

Other NDCs under ANDA 218985

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

FDA NDC Directory listings under ANDA 218985
Product	Strength	Form · route	Labeler	Product NDC
Varenicline	Varenicline tartrate .5 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-077
Varenicline	Varenicline tartrate 1 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-078