Varenicline (varenicline tartrate) NDC 31722-690

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-690Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0690Add 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
31722-690-31	31722069031	1 KIT in 1 CARTON (31722-690-31) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 23, 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
Generic name (nonproprietary): varenicline tartrate
Dosage form: Kit
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214571
Marketing start: Oct 23, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 31722-690_09a2708f-ed1b-b986-e063-6394a90a8fb5SPL ID 09a2708f-ed1b-b986-e063-6394a90a8fb5SPL set ID 7bd1abc8-2689-496b-b3f2-1cefe218ff5aRxCUI 636671, 636676, 749289, 749788UNII 82269ASB48UPC 0331722678568, 0331722679565

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

N431722069031 followed by a unit qualifier and the quantity

Package 31722-0690-31. 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 Nov 8, 2023.

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)