nicotine
- Product NDC
- 37808-383
- 11-digit product format
- 378080383
- Labeler code
- 37808
- Product ID
- 37808-383_fbecca27-2bc4-4673-ba65-b6fd6a446218
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA090711
- Marketing category
- ANDA
- Marketing start
- 2019-04-17
- 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
- nicotine
- 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 | 359818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 37808-383-10 | nicotine | 27 in 1 CONTAINER | LOZENGE | 27 | | 2 |
| 37808-383-10 | nicotine | 4 in 1 CARTON | LOZENGE | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-383 | NICOTINE LOZENGE [H E B] | 2 | Current NDC, Legacy NDC, 2 package rows | 20190521_98633912-74d8-49db-a03e-4a3f882297ac.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 |
|---|
| 37808-383-10 | 37808038310 | 4 CONTAINER in 1 CARTON (37808-383-10) / 27 LOZENGE in 1 CONTAINER | 4 container | 2019-04-17 | 0000-00-00 | No | No | Current |