Over-the-counter drug · ANDA
topcare nicotine (Nicotine polacrilex) NDC 36800-967
Nicotine 4 mg/1 · Gum, Chewing · Oral · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-967Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0967Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-967-78 | 3680009677836800096778 | 100 BLISTER PACK in 1 CARTON (36800-967-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 6, 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)
- topcare nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-967_96016d01-f4d7-4e67-a0c1-1e6c88ab5e1dSPL ID 96016d01-f4d7-4e67-a0c1-1e6c88ab5e1dSPL set ID 79d5ffe7-7fc1-4ab0-bce9-f6554b06dc0cRxCUI 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
N436800096778followed by a unit qualifier and the quantityPackage 36800-0967-78. 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 36800-967
- What is NDC 36800-967?
- 36800-967 is the product NDC for topcare nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare nicotine (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare nicotine?
- 14 other product NDCs are listed under this name. See all topcare nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare 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) |
|---|---|---|---|---|---|
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-460 | 36800-0460-25 |
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Topco Associates LLC | 76162-403 | 76162-0403-27 |
| topcare nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 76162-700 | 76162-0700-2776162-0700-58 |
| topcare nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-269 | 36800-0269-78 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-650 | 36800-0650-6036800-0650-78 |
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-863 | 36800-0863-78 |
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Topco Associates LLC | 36800-734 | 36800-0734-02 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 36800-957 | 36800-0957-02 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 36800-539 | 36800-0539-05 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 36800-873 | 36800-0873-0536800-0873-06 |
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 |
|---|---|---|---|---|
| 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 |
| careone nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-843 |
| 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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