Nicotine Polacrilex original (nicotine polacrilex) NDC 0363-1608

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-1608Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-1608Add 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
0363-1608-62	00363160862	110 BLISTER PACK in 1 CARTON (0363-1608-62) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014
0363-1608-98	00363160898	170 BLISTER PACK in 1 CARTON (0363-1608-98) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 originalSuffix: original
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 2 mg/1
Dosage form: Gum, Chewing
Route: Oral
Labeler: Walgreens
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074507
Marketing start: Jan 1, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 0363-1608_ce202975-a51b-43ae-aec6-d64f38f1be16SPL ID ce202975-a51b-43ae-aec6-d64f38f1be16SPL set ID f759d9b2-35e0-4b88-9219-4c0e483af5c4RxCUI 311975, 314119UNII 6M3C89ZY6R
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400363160862 followed by a unit qualifier and the quantity

Package 00363-1608-62. 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

Current FDA label (SPL), effective May 19, 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 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
Nicotine Polacrilex, Originalnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-286
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
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