What is NDC 55301-428?

55301-428 is the product NDC for Nicotine Polacrilex, Nicotine 2 mg/1 gum, chewing, listed with the FDA by AAFES/Your Military Exchanges. It has 1 package NDC, shown above in 10- and 11-digit form.

AAFES/Your Military Exchanges, NDC labeler code 55301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nicotine Polacrilex?

48 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nicotine Polacrilex NDC 55301-428 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55301-428Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55301-0428Add 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
55301-428-44	5530104284455301042844	100 BLISTER PACK in 1 CARTON (55301-428-44) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014

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 — 2 mg/1
Dosage form: Gum, Chewing
Route: Buccal
Labeler: AAFES/Your Military ExchangesNDC labeler code 55301
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078699
Marketing start: Jan 1, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 55301-428_34a618ae-4046-daa4-e063-6394a90a9fd2SPL ID 34a618ae-4046-daa4-e063-6394a90a9fd2SPL set ID 27308f6b-43b9-4b1d-af6b-7a39b79def03RxCUI 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455301042844 followed by a unit qualifier and the quantity

Package 55301-0428-44. 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 May 8, 2025.

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)

About NDC 55301-428

What is NDC 55301-428?: 55301-428 is the product NDC for Nicotine Polacrilex, Nicotine 2 mg/1 gum, chewing, listed with the FDA by AAFES/Your Military Exchanges. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nicotine Polacrilex.
What is the active ingredient?: Nicotine.
Who is the labeler?: AAFES/Your Military Exchanges, NDC labeler code 55301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicotine Polacrilex?: 48 other product NDCs are listed under this name. See all Nicotine Polacrilex 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 Nicotine Polacrilex NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-927	72224-0927-10
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-924	72224-0924-10
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-925	72224-0925-10
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-933	72224-0933-10
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-976	55910-0976-20
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Quitine LLC	84720-927	84720-0927-03
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Quitine LLC	84720-933	84720-0933-03
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-796	55910-0796-20
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-933	55910-0933-10
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	A-S Medication Solutions	50090-8146	50090-8146-00

All 49 Nicotine Polacrilex NDCs

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
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Dr. Reddy's Laboratories Inc.	75907-302
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Rugby Laboratories	0536-3112
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Walgreens	0363-9270
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	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-927
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Quitine LLC	84720-927
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Publix Supermarkets, Inc.	56062-428
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 Coated Mintnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	70000-0347