varenicline tartrate NDC 68462-894

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-894Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0894Add 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
68462-894-04	68462089404	1 BLISTER PACK in 1 CARTON (68462-894-04) / 56 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 22, 2023
68462-894-56	68462089456	56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56)Marketed from Aug 22, 2023

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: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214255
Marketing start: Aug 22, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 68462-894_67a82933-5f10-4a9a-8605-d09cd2f08d52SPL ID 67a82933-5f10-4a9a-8605-d09cd2f08d52SPL set ID e8a06e8e-1938-412c-a98a-28f0a29fe3acRxCUI 636671, 636676, 749289, 749788UNII 82269ASB48UPC 0368462893562, 0368462894569
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

N468462089404 followed by a unit qualifier and the quantity

Package 68462-0894-04. 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 Jan 7, 2026.

Indications (excerpt from the label)

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are 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 214255

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

FDA NDC Directory listings under ANDA 214255
Product	Strength	Form · route	Labeler	Product NDC
varenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-893
varenicline tartrate	—	Kit	Glenmark Pharmaceuticals Inc., USA	68462-895