What is NDC 59651-417?

59651-417 is the product NDC for Varenicline, Varenicline tartrate .5 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 59651-417 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-417Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0417Add 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
59651-417-56	5965104175659651041756	56 TABLET, FILM COATED in 1 BOTTLE (59651-417-56)Marketed from May 2, 2025

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
Active ingredients: Varenicline tartrate — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214595
Marketing start: May 2, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 59651-417_0004a0bb-87c0-46f8-b36a-95c98107395dSPL ID 0004a0bb-87c0-46f8-b36a-95c98107395dSPL set ID 0004a0bb-87c0-46f8-b36a-95c98107395dRxCUI 636671, 636676, 749289UNII 82269ASB48
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

N459651041756 followed by a unit qualifier and the quantity

Package 59651-0417-56. 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 May 8, 2025.

Indications (excerpt from the label)

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-417

What is NDC 59651-417?: 59651-417 is the product NDC for Varenicline, Varenicline tartrate .5 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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 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 214595

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

FDA NDC Directory listings under ANDA 214595
Product	Strength	Form · route	Labeler	Product NDC
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-418
Varenicline	—	Kit	Aurobindo Pharma Limited	59651-451