Nicotine Transdermal System step 2 (Nicotine) by Topco Associates LLC: new human otc drug listing
Nicotine Transdermal System step 2: new human otc drug listing. Dated 64 days ago, it serves as a historical benchmark. Score 45/100. As of 2026-11-03, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Free preview: all 13 published fields of this record are shown below. Locked: 499 related FdaNdcDirectoryPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Product | Nicotine Transdermal System step 2 |
| Generic name | Nicotine |
| NDC | 76162-741 |
| 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 14 mg/24h |
| Pharmacologic class | Cholinergic Nicotinic Agonist [EPC] |
| Marketing start | 2026-09-01 |
| Package configurations | 1 |
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- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-09-01
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Tue, 03 Nov 2026 18:09:00 GMT
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Peer benchmark and outreach value: Nicotine Transdermal System step 2 and 2,323 HUMAN OTC DRUG peers
- HUMAN OTC DRUG FdaNdcDirectoryPulse records like this one: 2,323
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every HUMAN OTC DRUG peer: $464,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
45 / 100 Launch Signal Score
- Brand or biologic launch.
- Class: Cholinergic Nicotinic Agonist [EPC].
What is the FdaNdcDirectoryPulse record for Nicotine Transdermal System step 2?
Nicotine Transdermal System step 2 by Topco Associates LLC: new human otc drug listing (NDA) starting 2026-09-01.
How does Nicotine Transdermal System step 2 compare to other FdaNdcDirectoryPulse records?
It is 64 days old; check the official source for later updates before acting.
Nicotine Transdermal System step 2 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Nicotine Transdermal System step 2 | HUMAN OTC DRUG | 2026-09-01 |
| BRYTLY | HUMAN OTC DRUG | 2026-10-16 |
| OMEPRAZOLE | HUMAN OTC DRUG | 2026-09-11 |
| Nicotine Transdermal System step 1 | HUMAN OTC DRUG | 2026-09-01 |
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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.