Over-the-counter drug · ANDA
CareOne Mini Nicotine Polacrilex (Nicotine polacrilex) NDC 41520-957
Nicotine 4 mg/1 · Lozenge · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-957-02 | 41520095702 | 3 CONTAINER in 1 CARTON (41520-957-02) / 27 LOZENGE in 1 CONTAINERMarketed from Aug 7, 2013 |
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)
- CareOne Mini Nicotine Polacrilex
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- American Sales CompanyNDC labeler code 41520
- 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 41520-957_2f975f2a-9842-47a6-9fa7-03241c550644SPL ID 2f975f2a-9842-47a6-9fa7-03241c550644SPL set ID d3591f0c-f638-485a-ab34-f71fce6a966fRxCUI 359818UNII 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
N441520095702followed by a unit qualifier and the quantityPackage 41520-0957-02. 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 41520-957
- What is NDC 41520-957?
- 41520-957 is the product NDC for CareOne Mini Nicotine Polacrilex (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CareOne Mini Nicotine Polacrilex (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CareOne Mini Nicotine Polacrilex?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 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 |
| exchange select nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-734 |
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