NICOTINE
- Product NDC
- 58602-904
- 11-digit product format
- 586020904
- Labeler code
- 58602
- Product ID
- 58602-904_810932e0-a982-400a-b43d-b847152f685b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA213266
- Marketing category
- ANDA
- Marketing start
- 2022-06-24
- 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
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 |
|---|
| 58602-904-07 | 58602090407 | 1 CONTAINER in 1 CARTON (58602-904-07) / 24 LOZENGE in 1 CONTAINER | 1 container | 2022-06-24 | No | No | Historical |
| 58602-904-51 | 58602090451 | 3 CONTAINER in 1 CARTON (58602-904-51) / 24 LOZENGE in 1 CONTAINER | 3 container | 2022-06-24 | No | No | Historical |
| 58602-904-65 | 58602090465 | 6 CONTAINER in 1 CARTON (58602-904-65) / 24 LOZENGE in 1 CONTAINER | 6 container | 2022-06-24 | No | No | Historical |