NICORETTE
- Product NDC
- 0135-0509
- 11-digit product format
- 001350509
- Labeler code
- 0135
- Product ID
- 0135-0509_b26eda42-5df1-45b9-bab1-f1c557a2bad1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Application
- NDA022360
- Marketing category
- NDA
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0509-02 | NICORETTE | 3 in 1 CARTON | LOZENGE | 3 | 15 | |
| 0135-0509-02 | NICORETTE | 27 in 1 CONTAINER | LOZENGE | 27 | 15 | |
| 0135-0509-03 | NICORETTE | 5 in 1 CARTON | LOZENGE | 5 | 15 | |
| 0135-0509-03 | NICORETTE | 27 in 1 CONTAINER | LOZENGE | 27 | 15 | |
| 0135-0509-04 | NICORETTE | 20 in 1 CONTAINER | LOZENGE | 20 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0509-02 | EA - Each | 0135-0509 | f97c9b19-e284-4eed-9dac-a897df1f14f4 | 1 | 2012-07-24 |
| 0135-0509-03 | EA - Each | 0135-0509 | aecea704-a2c0-46f9-834e-464df19a3336 | 1 | 2012-07-24 |
| 0135-0509-04 | EA - Each | 0135-0509 | 06cf46ae-b1f7-4224-9c7c-d9935cb04318 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 968849 | Nicorette 2 MG Oral Lozenge | PSN | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968851 | Nicorette 4 MG Oral Lozenge | PSN | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359817 | nicotine 2 MG Oral Lozenge | PSN | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359818 | nicotine 4 MG Oral Lozenge | PSN | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968849 | nicotine 2 MG Oral Lozenge [Nicorette] | SBD | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968851 | nicotine 4 MG Oral Lozenge [Nicorette] | SBD | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359817 | nicotine 2 MG Oral Lozenge | SCD | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359818 | nicotine 4 MG Oral Lozenge | SCD | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968849 | Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral Lozenge | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968849 | Nicorette 2 MG Oral Lozenge | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968849 | Nicorette 2 MG Troche | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968851 | Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral Lozenge | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 968851 | Nicorette 4 MG Oral Lozenge | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359817 | nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359817 | nicotine 2 MG Troche | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359818 | nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
| 359818 | nicotine 4 MG Troche | SY | fdee1637-8049-4bc5-b196-b6d854c9f9f3 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0509-02 | 00135050902 | 3 CONTAINER in 1 CARTON (0135-0509-02) > 27 LOZENGE in 1 CONTAINER | 3 container | 2010-03-01 | 0000-00-00 | No | No | Current |
| 0135-0509-03 | 00135050903 | 5 CONTAINER in 1 CARTON (0135-0509-03) > 27 LOZENGE in 1 CONTAINER | 5 container | 2010-03-01 | 0000-00-00 | No | No | Current |
| 0135-0509-04 | 00135050904 | 20 LOZENGE in 1 CONTAINER (0135-0509-04) | 20 lozenge | 2010-03-01 | 0000-00-00 | No | No | Current |