Nicotine Transdermal System
- Product NDC
- 50742-668
- 11-digit product format
- 507420668
- Labeler code
- 50742
- Product ID
- 50742-668_5244921a-4ef6-b582-e063-6294a90a8845
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Transdermal System
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA074612
- Marketing category
- ANDA
- Marketing start
- 2026-05-19
- Substance
- NICOTINE
- Active strength
- 7 mg/24h
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Transdermal System
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 7 mg/24h |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 198029, 198030, 198031 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50742-668-07 | Nicotine Transdermal System | 24 h in 1 POUCH | PATCH | 24 | | 1 |
| 50742-668-07 | Nicotine Transdermal System | 7 in 1 CARTON | PATCH | 7 | | 1 |
| 50742-668-14 | Nicotine Transdermal System | 14 in 1 CARTON | PATCH | 14 | | 1 |
| 50742-668-14 | Nicotine Transdermal System | 24 h in 1 POUCH | PATCH | 24 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50742-668-07 | 50742066807 | 7 POUCH in 1 CARTON (50742-668-07) / 24 h in 1 POUCH | 7 pouch | 2026-05-19 | No | No | Historical |
| 50742-668-14 | 50742066814 | 14 POUCH in 1 CARTON (50742-668-14) / 24 h in 1 POUCH | 14 pouch | 2026-05-19 | No | No | Historical |