NICORETTE
- Product NDC
- 0135-0636
- 11-digit product format
- 001350636
- Labeler code
- 0135
- Product ID
- 0135-0636_fd080df4-10ba-4b7e-a999-474f51610d2a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- ANDA077007
- Marketing category
- ANDA
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0636-01 | NICORETTE | 3 in 1 CARTON | LOZENGE | 3 | | 4 |
| 0135-0636-01 | NICORETTE | 72 in 1 CONTAINER | LOZENGE | 72 | | 4 |
| 0135-0636-02 | NICORETTE | 6 in 1 CARTON | LOZENGE | 6 | | 4 |
| 0135-0636-02 | NICORETTE | 144 in 1 CONTAINER | LOZENGE | 144 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0636 | NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC] | 4 | Current NDC, 4 package rows | 20250427_ffeb8286-860d-49f5-8df3-724afb4aaad8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0135-0636-01 | 00135063601 | 3 CONTAINER in 1 CARTON (0135-0636-01) / 72 LOZENGE in 1 CONTAINER | 3 container | 2022-06-01 | No | No | Historical |
| 0135-0636-02 | 00135063602 | 6 in 1 CARTON | | | | | Historical |