NICOTINE
- Product NDC
- 42507-343
- 11-digit product format
- 425070343
- Labeler code
- 42507
- Product ID
- 42507-343_ea59f977-2b62-4c7b-9735-99c8fd2f4ffe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA206394
- Marketing category
- ANDA
- Marketing start
- 2026-02-25
- 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
- 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 | 314119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-343-78 | NICOTINE | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 2 |
| 42507-343-78 | NICOTINE | 100 in 1 CARTON | GUM, CHEWING | 100 | | 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 |
|---|
| 42507-343-78 | 42507034378 | 100 BLISTER PACK in 1 CARTON (42507-343-78) / 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2026-02-25 | No | No | Historical |