Over-the-counter drug · ANDA
TopCare Nicotine (nicotine polacrilex) NDC 36800-029
Nicotine 2 mg/1 · Gum, Chewing · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-029-25 | 36800002925 | 110 BLISTER PACK in 1 CARTON (36800-029-25) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 20, 2005 |
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 — 2 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 076775
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 36800-029_15952d5c-9ddf-4951-bc63-58b36ce5a85fSPL ID 15952d5c-9ddf-4951-bc63-58b36ce5a85fSPL set ID beb2eddc-0fec-4f64-bceb-4e9bcee3616cRxCUI 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
N436800002925followed by a unit qualifier and the quantityPackage 36800-0029-25. 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.
Other NDCs under ANDA 076775
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 |
|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0029 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-029 |
| kirkland signature quit 2nicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-029 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-029 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0029 |
| CareOne nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-792 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-029 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-298 |
| Foster and Thrive Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1166 |
| up and up uncoated nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Target Corporation | 82442-029 |
| members mark nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-029 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | BJWC | 68391-029 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | H E B | 37808-781 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Safeway | 21130-389 |