Varenicline (varenicline tartrate) NDC 10135-808

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-808Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0808Add 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
10135-808-56	10135080856	56 TABLET, FILM COATED in 1 BOTTLE (10135-808-56)Marketed from Jan 1, 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 tartrate
Active ingredients: Varenicline tartrate — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Marlex Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217283
Marketing start: Jan 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 10135-808_4db2ad18-c1a0-81b8-e063-6394a90ac1d1SPL ID 4db2ad18-c1a0-81b8-e063-6394a90ac1d1SPL set ID 29b6b4ca-aeef-1295-e063-6394a90a21b9RxCUI 636671, 636676UNII 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

N410135080856 followed by a unit qualifier and the quantity

Package 10135-0808-56. 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 Mar 23, 2026.

Indications (excerpt from the label)

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline is 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)

Other NDCs under ANDA 217283

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

FDA NDC Directory listings under ANDA 217283
Product	Strength	Form · route	Labeler	Product NDC
Vareniclinevarenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-809