# Nicotine Transdermal System step 3 (Nicotine) by Topco Associates LLC: new human otc drug listing

**Launch Signal Score:** 45/100

| Field | Value |
|---|---|
| Product | Nicotine Transdermal System step 3 |
| Generic name | Nicotine |
| NDC | 76162-740 |
| Labeler | Topco Associates LLC |
| Product type | HUMAN OTC DRUG |
| Approval pathway | NDA |
| Application number | NDA020076 |
| Dosage form | PATCH, EXTENDED RELEASE |
| Route | TRANSDERMAL |
| Active ingredients | NICOTINE 7 mg/24h |
| Pharmacologic class | Cholinergic Nicotinic Agonist [EPC] |
| Marketing start | 2026-09-01 |
| Package configurations | 1 |

## Why this score
- Brand or biologic launch.
- Class: Cholinergic Nicotinic Agonist [EPC].

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=76162-740). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.