Nicotine Transdermal System
- Product NDC
- 3215-0120
- 11-digit product format
- 032150120
- Labeler code
- 3215
- Product ID
- 3215-0120_43e1a5a7-e10f-afa8-e063-6294a90a254e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Transdermal System
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Aveva Drug Delivery Systems, Inc.
- Application
- ANDA074612
- Marketing category
- ANDA
- Marketing start
- 2025-11-24
- Substance
- NICOTINE
- Active strength
- 7 mg/24h
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Transdermal System
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 7 mg/24h |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 198029, 198030, 198031 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 3215-0120-14 | Nicotine Transdermal System | 14 in 1 CARTON | PATCH | 14 | 1 | |
| 3215-0120-14 | Nicotine Transdermal System | 1 h in 1 PATCH | PATCH | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | PSN | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | PSN | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198029 | 24 HR nicotine 0.583 MG/HR Transdermal System | SCD | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198030 | 24 HR nicotine 0.875 MG/HR Transdermal System | SCD | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198029 | nicotine 0.583 MG/HR 24HR Transdermal Patch | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198030 | nicotine 0.875 MG/HR 24HR Transdermal Patch | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198029 | nicotine 14 MG per 24HR 1 Day Transdermal Patch | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198030 | nicotine 21 MG per 24HR 1 Day Transdermal Patch | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 55442645-fa9b-4a9b-81e2-345ad062a124 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 3215-0120-14 | 03215012014 | 14 PATCH in 1 CARTON (3215-0120-14) / 1 h in 1 PATCH | 14 patch | 2025-11-24 | No | No | Current |