Nicotine Transdermal System
- Product NDC
- 68001-433
- 11-digit product format
- 680010433
- Labeler code
- 68001
- Product ID
- 68001-433_312dca25-59f8-dffd-e063-6394a90adc8c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Transdermal System
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA074612
- Marketing category
- ANDA
- Marketing start
- 2024-06-27
- Substance
- NICOTINE
- Active strength
- 14 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 table| Ingredient | Strength |
|---|
| NICOTINE | 14 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 |
|---|
| 68001-433-88 | Nicotine Transdermal System | 1 h in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | | 4 |
| 68001-433-88 | Nicotine Transdermal System | 7 in 1 CARTON | PATCH, EXTENDED RELEASE | 7 | | 4 |
| 68001-433-90 | Nicotine Transdermal System | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | | 4 |
| 68001-433-90 | Nicotine Transdermal System | 1 h in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-433 | NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BLUEPOINT LABORATORIES] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250327_a8a769ce-e41a-696f-e053-2a95a90a6b18.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68001-433-88 | 68001043388 | 7 POUCH in 1 CARTON (68001-433-88) / 1 h in 1 POUCH | 7 pouch | 2024-06-27 | 0000-00-00 | No | No | Current |
| 68001-433-90 | 68001043390 | 14 POUCH in 1 CARTON (68001-433-90) / 1 h in 1 POUCH | 14 pouch | 2024-06-27 | 0000-00-00 | No | No | Current |