Nicotine
- Product NDC
- 68196-194
- 11-digit product format
- 681960194
- Labeler code
- 68196
- Product ID
- 68196-194_0688260f-58f8-41f6-8b77-4e16833f58cc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Sam's West Inc
- Application
- NDA020165
- Marketing category
- NDA
- Marketing start
- 2012-03-02
- Substance
- NICOTINE
- Active strength
- 21 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
- Brand name suffix
- transdermal system
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 21 mg/24h |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 198030 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68196-194-03 | Nicotinetransdermal system | 21 in 1 CARTON | PATCH, EXTENDED RELEASE | 21 | | 10 |
| 68196-194-03 | Nicotinetransdermal system | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68196-194 | NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240322_cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7.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 |
|---|
| 68196-194-03 | 68196019403 | 21 PATCH in 1 CARTON (68196-194-03) > 24 h in 1 PATCH | 21 patch | 2012-03-02 | 0000-00-00 | No | No | Current |