NICOTINE
- Product NDC
- 42507-690
- 11-digit product format
- 425070690
- Labeler code
- 42507
- Product ID
- 42507-690_b173622b-e105-466d-8858-f95a2c866271
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA077007
- Marketing category
- ANDA
- Marketing start
- 2026-03-18
- Substance
- NICOTINE
- Active strength
- 4 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
- Listing expiration
- 2027-12-31
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 |
|---|
| 42507-690-09 | NICOTINE | 27 in 1 BOTTLE | LOZENGE | 27 | | 2 |
| 42507-690-10 | NICOTINE | 4 in 1 CARTON | LOZENGE | 4 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-690-09 | 42507069009 | 27 in 1 BOTTLE | | | | | Historical |
| 42507-690-10 | 42507069010 | 4 BOTTLE in 1 CARTON (42507-690-10) / 27 LOZENGE in 1 BOTTLE (42507-690-09) | 4 bottle | 2026-03-18 | No | No | Historical |