Nicotine Polacrilex, Original NDC 68016-286

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-286Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0286Add 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
68016-286-62	68016028662	11 BLISTER PACK in 1 CARTON (68016-286-62) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 1, 2013

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, Original
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 2 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 074507
Marketing start: Jul 1, 2013
Marketing end: Dec 31, 2026
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 68016-286_b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4SPL ID b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4SPL set ID cb67cd5e-9264-4530-a678-da299476f356RxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0840986029875, 0840986029882
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

N468016028662 followed by a unit qualifier and the quantity

Package 68016-0286-62. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 074507

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

FDA NDC Directory listings under ANDA 074507
Product	Strength	Form · route	Labeler	Product NDC
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	The Kroger Co.	30142-859
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	McKesson Corporation dba SKY Packaging	63739-371
Nicotine Polacrilex originalnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Walgreens	0363-1608
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Walgreens	0363-9290
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Rugby Laboratories	0536-3029
Nicotine Polacrilex Original Flavornicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Publix Supermarkets, Inc.	56062-608
Nicotine Polacrilex originalnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	CVS Pharmacy	69842-608
Nicotine Polacrilex Originalnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	70000-0345
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	P & L Development, LLC	59726-929
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	AmerisourceBergen (Good Neighbor Pharmacy) 46122	46122-719

Nicotine Polacrilex, Original (nicotine polacrilex) NDC 68016-286