Nicotine Transdermal System
- Product NDC
- 76282-781
- 11-digit product format
- 762820781
- Labeler code
- 76282
- Product ID
- 76282-781_2aec5dc5-7c75-43f4-b724-de29ac1f84cb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine
- Dosage form
- FILM, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- EXELAN PHARMACEUTICALS, INC.
- Application
- ANDA074612
- Marketing category
- ANDA
- Marketing start
- 2025-10-13
- 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 |
|---|---|---|---|---|---|---|
| 76282-781-40 | Nicotine Transdermal System | 14 in 1 CARTON | FILM, EXTENDED RELEASE | 14 | 1 | |
| 76282-781-40 | Nicotine Transdermal System | 1 h in 1 POUCH | FILM, EXTENDED RELEASE | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | PSN | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | PSN | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198029 | 24 HR nicotine 0.583 MG/HR Transdermal System | SCD | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198030 | 24 HR nicotine 0.875 MG/HR Transdermal System | SCD | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198029 | nicotine 0.583 MG/HR 24HR Transdermal Patch | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198030 | nicotine 0.875 MG/HR 24HR Transdermal Patch | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198029 | nicotine 14 MG per 24HR 1 Day Transdermal Patch | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198030 | nicotine 21 MG per 24HR 1 Day Transdermal Patch | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76282-781-40 | 76282078140 | 14 POUCH in 1 CARTON (76282-781-40) / 1 h in 1 POUCH | 14 pouch | 2025-10-13 | No | No | Current |