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 Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-967-78 | 36800096778 | 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 LLC
- 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 |
|---|---|---|---|---|
| Up And Up Coated Fruit Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-971 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer, Inc. | 79481-0601 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-689 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-2309 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-003 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-693 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0309 |
| kirkland signature quit 4nicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-309 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Kroger Company | 30142-848 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-019 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8600 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-309 |
| careone nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-843 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7971 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-4111 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-650 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-309 |
| blipnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-971 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7103 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0053 |
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