nicotine lozenge
- Product NDC
- 37808-674
- 11-digit product format
- 378080674
- Labeler code
- 37808
- Product ID
- 37808-674_f186f7fc-7b7a-4029-a404-99e5f2e1f557
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA077007
- Marketing category
- ANDA
- Marketing start
- 2019-04-16
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nicotine lozenge
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359817 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 37808-674-03 | nicotine lozenge | 1 in 1 CARTON | LOZENGE | 1 | | 4 |
| 37808-674-03 | nicotine lozenge | 24 in 1 CONTAINER | LOZENGE | 24 | | 4 |
| 37808-674-10 | nicotine lozenge | 4 in 1 CARTON | LOZENGE | 4 | | 4 |
| 37808-674-10 | nicotine lozenge | 27 in 1 CONTAINER | LOZENGE | 27 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-674 | NICOTINE LOZENGE (NICOTINE POLACRILEX) LOZENGE [H E B] | 2 | Current NDC, Legacy NDC, 4 package rows | 20190424_db78d030-7abf-494f-94ca-4a385f519faf.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 |
|---|
| 37808-674-03 | 37808067403 | 1 CONTAINER in 1 CARTON (37808-674-03) / 24 LOZENGE in 1 CONTAINER | 1 container | 2019-04-16 | 0000-00-00 | No | No | Current |
| 37808-674-10 | 37808067410 | 4 CONTAINER in 1 CARTON (37808-674-10) / 27 LOZENGE in 1 CONTAINER | 4 container | 2019-04-16 | 0000-00-00 | No | No | Current |