Over-the-counter drug · ANDA
mini nicotine (Nicotine polacrilex) NDC 41250-637
Nicotine 4 mg/1 · Lozenge · Oral · Meijer Distribution Inc
NDC codes
FDA NDC DirectoryProduct NDC (as listed)41250-637Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0637Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41250-637-07 | 4125006370741250063707 | 3 CONTAINER in 1 CARTON (41250-637-07) / 27 LOZENGE in 1 CONTAINER (41250-637-09)Marketed from May 16, 2019 |
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)
- mini nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Meijer Distribution IncNDC labeler code 41250
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203690
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 41250-637_0d847f42-78fd-436d-8523-669d93f0a4baSPL ID 0d847f42-78fd-436d-8523-669d93f0a4baSPL set ID 426b2f92-561d-476b-959c-cdd0fa37be56RxCUI 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
N441250063707followed by a unit qualifier and the quantityPackage 41250-0637-07. 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 41250-637
- What is NDC 41250-637?
- 41250-637 is the product NDC for mini nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Meijer Distribution Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- mini nicotine (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Meijer Distribution Inc, NDC labeler code 41250. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for mini nicotine?
- 16 other product NDCs are listed under this name. See all mini nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other mini nicotine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| mini nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer, Inc. | 79481-0734 | 79481-0734-02 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer, Inc. | 79481-0957 | 79481-0957-02 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer, Inc. | 79481-0301 | 79481-0301-0079481-0301-01 |
| Mini Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer, Inc. | 79481-0223 | 79481-0223-0179481-0223-02 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-264 | 59726-0264-2759726-0264-35 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-662 | 55910-0662-20 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-264 | 83253-0264-1883253-0264-2783253-0264-81 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-716 | 46122-0716-1546122-0716-1646122-0716-60 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. (see also Equate) | 79903-128 | 79903-0128-0879903-0128-27 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-436 | 49035-0436-0849035-0436-27 |
Other NDCs under ANDA 203690
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 |
|---|---|---|---|---|
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-077 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-223 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-642 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-734 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-808 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-957 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-734 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | BJWC | 68391-957 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Blip Products, Inc. | 82966-222 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Blip Products, Inc. | 82966-303 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Blip Products, Inc. | 82966-734 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Blip Products, Inc. | 82966-957 |
| CareOne Mini Nicotine Polacrilexnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | American Sales Company | 41520-957 |
| CareOne Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-734 |
| Dg Health Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp Inc | 55910-669 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-734 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-791 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-900 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-104 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-160 |
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