NICORETTE
- Product NDC
- 0135-0626
- 11-digit product format
- 001350626
- Labeler code
- 0135
- Product ID
- 0135-0626_36c1b8d5-e876-dc22-e063-6294a90aff3b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA021330
- Marketing category
- NDA
- Marketing start
- 2019-04-11
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0626 | NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240711_f350e050-2173-43e0-8738-848382ce0700.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 |
|---|
| 0135-0626-01 | 00135062601 | 1 CONTAINER in 1 CARTON (0135-0626-01) / 20 LOZENGE in 1 CONTAINER | 1 container | 2019-04-11 | 0000-00-00 | No | No | Current |
| 0135-0626-02 | 00135062602 | 4 CONTAINER in 1 CARTON (0135-0626-02) / 20 LOZENGE in 1 CONTAINER | 4 container | 2019-04-11 | 0000-00-00 | No | No | Current |
| 0135-0626-03 | 00135062603 | 6 CONTAINER in 1 CARTON (0135-0626-03) / 20 LOZENGE in 1 CONTAINER | 6 container | 2019-10-23 | 0000-00-00 | No | No | Current |