varenicline tartrate NDC 42571-460

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-460Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0460Add 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
42571-460-82	42571046082	56 TABLET, FILM COATED in 1 BOTTLE (42571-460-82)Marketed from Dec 1, 2025
42571-460-88	42571046088	1 BLISTER PACK in 1 CARTON (42571-460-88) / 56 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 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 tartrate
Generic name (nonproprietary): varenicline tartrate
Active ingredients: Varenicline tartrate — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218302
Marketing start: Dec 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 42571-460_426f1bdc-211b-b246-e063-6394a90a8de3SPL ID 426f1bdc-211b-b246-e063-6394a90a8de3SPL set ID ee603a5d-9a3c-4dbd-ba89-faf253dc8c42RxCUI 636671, 636676, 749289, 749788UNII 82269ASB48UPC 0342571460822, 0342571459826, 0342571460884, 0342571475840
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

N442571046082 followed by a unit qualifier and the quantity

Package 42571-0460-82. 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 Oct 31, 2025.

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 218302

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

FDA NDC Directory listings under ANDA 218302
Product	Strength	Form · route	Labeler	Product NDC
varenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-459
Varenicline tartrate	—	Kit	Micro Labs Limited	42571-475