Over-the-counter drug · ANDA
care one nicotine (Nicotine polacrilex) NDC 41520-352
Nicotine 2 mg/1 · Gum, Chewing · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-352-78 | 4152003527841520035278 | 100 BLISTER PACK in 1 CARTON (41520-352-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 29, 2017 |
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)
- care one nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- 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 078547
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 41520-352_eb56b163-b633-4e73-8b87-8b558af0cce6SPL ID eb56b163-b633-4e73-8b87-8b558af0cce6SPL set ID e9558a4e-a0ad-4391-9b9c-85edb61523c1RxCUI 314119UNII 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
N441520035278followed by a unit qualifier and the quantityPackage 41520-0352-78. 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 41520-352
- What is NDC 41520-352?
- 41520-352 is the product NDC for care one nicotine (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, 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?
- care one nicotine (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 care one nicotine?
- 2 other product NDCs are listed under this name. See all care one nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other care one 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) |
|---|---|---|---|---|---|
| Care One Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-854 | 41520-0854-78 |
| care one nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | American Sales Company | 41520-873 | 41520-0873-05 |
Other NDCs under ANDA 078547
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 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-352 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-352 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1164 |
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-1352 |
| quitine nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-352 |