Nicotine
- Product NDC
- 0536-1106
- 11-digit product format
- 005361106
- Labeler code
- 0536
- Product ID
- 0536-1106_4db08daa-369f-52ce-4876-e03455838521
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Rugby Laboratories
- Application
- NDA020076
- Marketing category
- NDA
- Marketing start
- 2016-04-01
- 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
- Brand name suffix
- transdermal system step 3
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1106-52 | Nicotine transdermal system step 3 | 7 in 1 CARTON | PATCH, EXTENDED RELEASE | 7 | | 11 |
| 0536-1106-52 | Nicotine transdermal system step 3 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 11 |
| 0536-1106-88 | Nicotine transdermal system step 3 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 11 |
| 0536-1106-88 | Nicotine transdermal system step 3 | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1106 | NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [RUGBY LABORATORIES] | 10 | Current NDC, Legacy NDC, 4 package rows | 20240726_ae406389-0f83-d5c8-bd2f-56075e57453a.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 |
|---|
| 0536-1106-52 | 00536110652 | 7 PATCH in 1 CARTON (0536-1106-52) / 24 h in 1 PATCH | 7 patch | 2026-03-20 | | No | No | Historical |
| 0536-1106-88 | 00536110688 | 14 PATCH in 1 CARTON (0536-1106-88) / 24 h in 1 PATCH | 14 patch | 2016-04-01 | 0000-00-00 | No | No | Current |