nicotine
- Product NDC
- 45802-827
- 11-digit product format
- 458020827
- Labeler code
- 45802
- Product ID
- 45802-827_35ce50f9-5c88-47c4-b8ef-58edd8945818
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA206394
- Marketing category
- ANDA
- Marketing start
- 2023-05-22
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6M3C89ZY6R | NICOTINE | 54-11-5 | NICOTINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45802-827-25 | 45802082725 | 110 BLISTER PACK in 1 CARTON (45802-827-25) / 1 GUM, CHEWING in 1 BLISTER PACK | 110 blister pack | 2023-05-22 | No | No | Historical |