Nicotine Polacrilex NDC 0363-9270

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-9270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-9270Add 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
0363-9270-10	00363927010	100 BLISTER PACK in 1 CARTON (0363-9270-10) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 30, 2021
0363-9270-16	00363927016	160 BLISTER PACK in 1 CARTON (0363-9270-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 30, 2021
0363-9270-20	00363927020	20 BLISTER PACK in 1 CARTON (0363-9270-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 30, 2021

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
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 078699
Marketing start: Apr 30, 2021
Marketing end: Sep 28, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 0363-9270_0e447180-c9e7-4464-b777-b63f320b5c1fSPL ID 0e447180-c9e7-4464-b777-b63f320b5c1fSPL set ID fe5c4bfd-a792-4923-b2db-16be44d599eaRxCUI 314119UNII 6M3C89ZY6RUPC 0311917032795
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

N400363927010 followed by a unit qualifier and the quantity

Package 00363-9270-10. 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 12, 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 078699

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

FDA NDC Directory listings under ANDA 078699
Product	Strength	Form · route	Labeler	Product NDC
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	AmerisourceBergen (Good Neighbor Pharmacy) 46122	46122-717
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Rising Pharma Holdings, Inc.	57237-322
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	70000-0347
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Quitine LLC	84720-927
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	AAFES/Your Military Exchanges	55301-428
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-280
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-284
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-559
Nicotine Polacrilex coated mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	CVS Pharmacy	69842-428
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-927
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Publix Supermarkets, Inc.	56062-428
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Rugby Laboratories	0536-3112
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Dr. Reddy's Laboratories Inc.	75907-302