NICORETTE
- Product NDC
- 0135-1500
- 11-digit product format
- 001351500
- Labeler code
- 0135
- Product ID
- 0135-1500_7b5518a7-f738-4f58-9c16-f6092a3885a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA022360
- Marketing category
- NDA
- Marketing start
- 2022-06-01
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- 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
- NICORETTE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359817, 359818, 968849, 968851 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-1500-01 | NICORETTE | 20 in 1 CONTAINER | LOZENGE | 20 | | 4 |
| 0135-1500-02 | NICORETTE | 3 in 1 CARTON | LOZENGE | 3 | | 4 |
| 0135-1500-02 | NICORETTE | 27 in 1 VIAL | LOZENGE | 27 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-1500 | NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20250427_c7f32ab1-f6bd-46f5-9852-8eb5b78a3326.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 |
|---|
| 0135-1500-01 | 00135150001 | 20 LOZENGE in 1 CONTAINER (0135-1500-01) | 20 lozenge | 2022-06-01 | 0000-00-00 | No | No | Current |
| 0135-1500-02 | 00135150002 | 3 VIAL in 1 CARTON (0135-1500-02) / 27 LOZENGE in 1 VIAL | 3 vial | 2022-06-01 | 0000-00-00 | No | No | Current |