Over-the-counter drug · ANDA
Nicotine Mini (Nicotine polacrilex) NDC 57237-321
Nicotine 4 mg/1 · Lozenge · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)57237-321Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0321Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-321-42 | 57237032142 | 1 BOTTLE, PLASTIC in 1 BOX (57237-321-42) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 10, 2023 | |
| 57237-321-72 | 57237032172 | 3 BOTTLE, PLASTIC in 1 BOX (57237-321-72) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 10, 2023 | |
| 57237-321-81 | 57237032181 | 3 BOTTLE, PLASTIC in 1 BOX (57237-321-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC (57237-321-27)Marketed 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 MiniSuffix: Mini
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- 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 207868
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 57237-321_02faa0ad-b311-4bfa-9e0f-b085939d7063SPL ID 02faa0ad-b311-4bfa-9e0f-b085939d7063SPL set ID 05990040-5bd7-4622-8fe3-2d7573904dfaRxCUI 359817, 359818UNII 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
N457237032142followed by a unit qualifier and the quantityPackage 57237-0321-42. 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 .
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.
About NDC 57237-321
- What is NDC 57237-321?
- 57237-321 is the product NDC for Nicotine Mini (nicotine polacrilex), Nicotine 4 mg/1 lozenge, 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 Mini (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 Mini?
- 32 other product NDCs are listed under this name. See all Nicotine Mini NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Mini products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-739 | 72288-0739-14 |
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-797 | 72288-0797-14 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-375 | 72288-0375-0172288-0375-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-569 | 72288-0569-0172288-0569-0472288-0569-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-652 | 59726-0652-0459726-0652-27 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-979 | 83253-0979-1883253-0979-2783253-0979-72+1 more |
| nicotine mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-6011 | 00363-6011-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-7051 | 00363-7051-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rising Pharma Holdings, Inc. | 57237-320 | 57237-0320-4257237-0320-7257237-0320-81 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | HC Jones, Inc. | 83253-262 | 83253-0262-1883253-0262-2783253-0262-81 |
Other NDCs under ANDA 207868
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-662 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1239 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1241 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0262 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0264 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-436 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-0262 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-715 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-716 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | ATLANTIC BIOLOGICALS CORP. | 17856-1239 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | ATLANTIC BIOLOGICALS CORP. | 17856-1241 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rising Pharma Holdings, Inc. | 57237-320 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-493 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Chain Drug Consortium, LLC | 68016-087 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3315 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-731 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0560 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0559 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. (see also Equate) | 79903-127 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | HC Jones, Inc. | 83253-262 |
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