Over-the-counter drug · ANDA
careone nicotine (Nicotine polacrilex) NDC 41520-843
Nicotine 4 mg/1 · Gum, Chewing · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-843-60 | 4152008436041520084360 | 20 BLISTER PACK in 1 CARTON (41520-843-60) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 29, 2017 | |
| 41520-843-78 | 4152008437841520084378 | 100 BLISTER PACK in 1 CARTON (41520-843-78) / 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)
- careone nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 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 206393
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 41520-843_b753ec3f-799d-41c6-81e8-4f8e73c410c5SPL ID b753ec3f-799d-41c6-81e8-4f8e73c410c5SPL set ID be90d633-e928-484c-9fa7-d363c23bb89cRxCUI 311975UNII 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
N441520084360followed by a unit qualifier and the quantityPackage 41520-0843-60. 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 41520-843
- What is NDC 41520-843?
- 41520-843 is the product NDC for careone nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by American Sales Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- careone 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 careone nicotine?
- 5 other product NDCs are listed under this name. See all careone nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other careone 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) |
|---|---|---|---|---|---|
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-711 | 41520-0711-6041520-0711-78 |
| CareOne nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-792 | 41520-0792-25 |
| careone nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-891 | 41520-0891-25 |
| CareOne Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-734 | 41520-0734-02 |
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-701 | 41520-0701-05 |
Other NDCs under ANDA 206393
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 |
|---|---|---|---|---|
| topcare nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-967 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-309 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8600 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | HyVee Inc | 42507-309 |
| Coated Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-369 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-4111 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-689 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-693 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0053 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Padagis Israel Pharmaceuticals Ltd | 45802-651 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-755 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-6674 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-6695 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1193 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-2309 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-309 |
| quitine nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-103 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Kroger Company | 30142-848 |
| blipnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-971 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 |
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