Nicotine
- Product NDC
- 59450-003
- 11-digit product format
- 594500003
- Labeler code
- 59450
- Product ID
- 59450-003_3545efa6-1a37-cbdd-ccdd-167992151d52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- The Kroger Co.
- Application
- NDA020076
- Marketing category
- NDA
- Marketing start
- 2015-08-25
- 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 |
|---|
| 59450-003-74 | Nicotine transdermal system step 1 | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | | 9 |
| 59450-003-74 | Nicotine transdermal system step 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | | 9 |
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 [THE KROGER CO.] | 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 [THE KROGER CO.] | 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 [THE KROGER CO.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59450-003 | 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 [THE KROGER CO.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240726_13cdd780-4196-685b-3cab-f9694a327618.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 |
|---|
| 59450-003-74 | 59450000374 | 14 PATCH in 1 CARTON (59450-003-74) / 24 h in 1 PATCH | 14 patch | 2015-08-25 | 0000-00-00 | No | No | Current |