What is NDC 68462-895?

68462-895 is the product NDC for varenicline tartrate kit, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 tartrate?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

varenicline tartrate NDC 68462-895

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-895Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0895Add 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
68462-895-04	6846208950468462089504	1 KIT in 1 CARTON (68462-895-04) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACKMarketed 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
Dosage form: Kit
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
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
Identifiers: Product ID 68462-895_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

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

N468462089504 followed by a unit qualifier and the quantity

Package 68462-0895-04. 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)

About NDC 68462-895

What is NDC 68462-895?: 68462-895 is the product NDC for varenicline tartrate kit, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: varenicline tartrate.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 tartrate?: 21 other product NDCs are listed under this name. See all varenicline tartrate 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 tartrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
varenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-459	42571-0459-82
varenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-460	42571-0460-8242571-0460-88
Varenicline tartrate	—	Kit	Micro Labs Limited	42571-475	42571-0475-84
varenicline tartrate	—	KitOral	Dr. Reddys Laboratories Inc.	43598-022	43598-0022-56
varenicline tartrate	—	KitOral	Dr. Reddys Laboratories Inc.	43598-023	43598-0023-53
varenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Dr. Reddys Laboratories Inc.	43598-907	43598-0907-56
varenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Dr. Reddys Laboratories Inc.	43598-908	43598-0908-56
Varenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Indoco Remedies Limited	14445-153	14445-0153-56
Varenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Indoco Remedies Limited	14445-154	14445-0154-0214445-0154-56
Varenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7996	50090-7996-00

All 22 varenicline tartrate NDCs

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	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-894