NICOTINE
- Product NDC
- 58602-722
- 11-digit product format
- 586020722
- Labeler code
- 58602
- Product ID
- 58602-722_cfe6fb63-2897-4e76-8288-1389f363b3c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX MINI
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA215357
- Marketing category
- ANDA
- Marketing start
- 2022-11-03
- 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 |
|---|
| 58602-722-81 | 58602072281 | 4 CONTAINER in 1 CARTON (58602-722-81) / 27 LOZENGE in 1 CONTAINER | 4 container | 2022-11-03 | No | No | Historical |
| 58602-722-84 | 58602072284 | 3 CONTAINER in 1 CARTON (58602-722-84) / 27 LOZENGE in 1 CONTAINER | 3 container | 2022-11-03 | No | No | Historical |
| 58602-722-85 | 58602072285 | 5 CONTAINER in 1 CARTON (58602-722-85) / 27 LOZENGE in 1 CONTAINER | 5 container | 2022-11-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Nicotine Polacrilex Lozenge | Aurohealth LLC | APL HEALTHCARE LIMITED | 2022-11-03 | Human OTC Drug Label | 1 |