Nicotine
- Product NDC
- 0363-0455
- 11-digit product format
- 003630455
- Labeler code
- 0363
- Product ID
- 0363-0455_d77c94ef-97ae-ba1a-6f49-b8cec31b4220
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Walgreens Company
- Application
- NDA020076
- Marketing category
- NDA
- Marketing start
- 2015-09-01
- 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 step 1
- 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 | 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 |
|---|
| 0363-0455-70 | Nicotine transdermal system step 1 | 7 in 1 CARTON | PATCH, EXTENDED RELEASE | 7 | | 10 |
| 0363-0455-70 | Nicotine transdermal system step 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 10 |
| 0363-0455-74 | Nicotine transdermal system step 1 | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | | 10 |
| 0363-0455-74 | Nicotine transdermal system step 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NICOTINE | ACTIVE INGREDIENT | 6M3C89ZY6R | 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 [WALGREENS COMPANY] | 2 | |
| NICOTINE | ACTIVE MOIETY | 6M3C89ZY6R | 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 [WALGREENS COMPANY] | 2 | |
| Methacrylic Acid | INACTIVE INGREDIENT | 1CS02G8656 | 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 [WALGREENS COMPANY] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-0455 | 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 [WALGREENS COMPANY] | 10 | Current NDC, Legacy NDC, 4 package rows | 20240726_de471db4-b332-0490-198d-d35480272874.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 |
|---|
| 0363-0455-70 | 00363045570 | 7 PATCH in 1 CARTON (0363-0455-70) / 24 h in 1 PATCH | 7 patch | 2015-09-01 | 0000-00-00 | No | No | Current |
| 0363-0455-74 | 00363045574 | 14 PATCH in 1 CARTON (0363-0455-74) / 24 h in 1 PATCH | 14 patch | 2015-09-01 | 0000-00-00 | No | No | Current |