Nicotine Transdermal System Patch
- Product NDC
- 68001-699
- 11-digit product format
- 680010699
- Labeler code
- 68001
- Product ID
- 68001-699_4856e41f-dd51-0ee5-e063-6294a90a228f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Transdermal System Patch
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- BluePoint Laboratories
- Application
- NDA020076
- Marketing category
- NDA
- Marketing start
- 2026-05-11
- Substance
- NICOTINE
- Active strength
- 21 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 Patch
- Brand name suffix
- Step 1
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 21 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 |
|---|
| 68001-699-88 | Nicotine Transdermal System PatchStep 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 1 |
| 68001-699-88 | Nicotine Transdermal System PatchStep 1 | 7 in 1 CARTON | PATCH, EXTENDED RELEASE | 7 | | 1 |
| 68001-699-90 | Nicotine Transdermal System PatchStep 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 1 |
| 68001-699-90 | Nicotine Transdermal System PatchStep 1 | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | | 1 |
| 68001-699-91 | Nicotine Transdermal System PatchStep 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 1 |
| 68001-699-91 | Nicotine Transdermal System PatchStep 1 | 28 in 1 CARTON | PATCH, EXTENDED RELEASE | 28 | | 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 |
|---|
| 68001-699-88 | 68001069988 | 7 PATCH in 1 CARTON (68001-699-88) / 24 h in 1 PATCH | 7 patch | 2026-05-11 | No | No | Historical |
| 68001-699-90 | 68001069990 | 14 PATCH in 1 CARTON (68001-699-90) / 24 h in 1 PATCH | 14 patch | 2026-05-11 | No | No | Historical |
| 68001-699-91 | 68001069991 | 28 PATCH in 1 CARTON (68001-699-91) / 24 h in 1 PATCH | 28 patch | 2026-05-11 | No | No | Historical |