Nicotine Polacrilex NDC 68016-293

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-293Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0293Add 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
68016-293-44	68016029344	100 BLISTER PACK in 1 CARTON (68016-293-44) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 1, 2017

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): Nicotine Polacrilex
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 4 mg/1
Dosage form: Gum, Chewing
Route: Buccal
Labeler: Chain Drug Consortium, LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204833
Marketing start: Oct 1, 2017
Marketing end: Feb 28, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 68016-293_692c9f96-0fb8-4d22-908b-4ffbff764fb0SPL ID 692c9f96-0fb8-4d22-908b-4ffbff764fb0SPL set ID 9c115cd5-1952-4f1e-8e88-27f2c528e91fRxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0840986034862
Pharmacologic class: 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468016029344 followed by a unit qualifier and the quantity

Package 68016-0293-44. 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 26, 2026.

Indications (excerpt from the label)

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204833

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

FDA NDC Directory listings under ANDA 204833
Product	Strength	Form · route	Labeler	Product NDC
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-933
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Family Dollar (FAMILY WELLNESS)	55319-966
Nicotine Polacrilex coated ice mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	AmerisourceBergen (Good Neighbor Pharmacy) 46122	46122-449
Nicotine Polacrilex Coated Ice Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	70000-0344
Nicotine Polacrilex coated ice mintnicotine polacrilex gum	Nicotine 4 mg/1	Gum, ChewingBuccal	CVS Pharmacy	69842-217
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Walgreens	0363-3290