What is NDC 57237-323?

57237-323 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 gum, chewing, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 57237-323 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-323Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0323Add 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
57237-323-01	5723703230157237032301	100 BLISTER PACK in 1 CARTON (57237-323-01) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Aug 10, 2023
57237-323-11	5723703231157237032311	110 BLISTER PACK in 1 CARTON (57237-323-11) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 8, 2025
57237-323-50	5723703235057237032350	50 BLISTER PACK in 1 CARTON (57237-323-50) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 8, 2025

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: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
Marketing start: Aug 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 57237-323_9230a5f3-bfa3-4a70-8e91-8df2736d9a29SPL ID 9230a5f3-bfa3-4a70-8e91-8df2736d9a29SPL set ID e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71RxCUI 311975UNII 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

N457237032301 followed by a unit qualifier and the quantity

Package 57237-0323-01. 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 Dec 6, 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 57237-323

What is NDC 57237-323?: 57237-323 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 gum, chewing, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, 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?: Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 078697

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

FDA NDC Directory listings under ANDA 078697
Product	Strength	Form · route	Labeler	Product NDC
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dr. Reddy's Laboratories Inc.	75907-303
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	Rugby Laboratories	0536-3113
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Walgreens	0363-9330
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	AmerisourceBergen (Good Neighbor Pharmacy) 46122	46122-718
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	A-S Medication Solutions	50090-8146
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	AAFES/Your Military Exchanges	55301-429
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-796
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-976
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-933
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Quitine LLC	84720-933
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	Publix Supermarkets, Inc.	56062-429
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-281
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-285
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	Chain Drug Consortium, LLC	68016-560
Nicotine Polacrilex coated mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	CVS Pharmacy	69842-430
Nicotine Polacrilex Coated Mintnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	70000-0343