Over-the-counter drug · ANDA
nicotine (nicotine polarilex) NDC 41250-201
Nicotine 2 mg/1 · Lozenge · Oral · Meijer Distribution Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41250-201-05 | 41250020105 | 3 CONTAINER in 1 CARTON (41250-201-05) / 24 LOZENGE in 1 CONTAINER (41250-201-03)Marketed from Jan 15, 2010 | |
| 41250-201-10 | 41250020110 | 4 CONTAINER in 1 CARTON (41250-201-10) / 27 LOZENGE in 1 CONTAINER (41250-201-09)Marketed from Mar 31, 2026 |
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
- Generic name (nonproprietary)
- nicotine polarilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Meijer Distribution Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090821
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 41250-201_ba98e47a-d334-4f96-96ab-3b0e622215aaSPL ID ba98e47a-d334-4f96-96ab-3b0e622215aaSPL set ID 9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4dRxCUI 359817UNII 6M3C89ZY6RUPC 0012345678905
- 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
N441250020105followed by a unit qualifier and the quantityPackage 41250-0201-05. 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.
Other NDCs under ANDA 090821
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 |
|---|---|---|---|---|
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0201 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 59779-201 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 59779-424 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-702 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0424 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-201 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Strategic Sourcing Services LLC | 70677-1174 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Strategic Sourcing Services LLC | 70677-1175 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-424 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-0201 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-0424 |