NICOTINE
- Product NDC
- 58602-905
- 11-digit product format
- 586020905
- Labeler code
- 58602
- Product ID
- 58602-905_56a1c778-fc3b-4848-a7e0-b1e4f0a8fbc2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA213266
- Marketing category
- ANDA
- Marketing start
- 2021-10-29
- 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 |
|---|
| 58602-905-07 | 58602090507 | 1 CONTAINER in 1 CARTON (58602-905-07) / 24 LOZENGE in 1 CONTAINER | 1 container | 2021-10-29 | No | No | Historical |
| 58602-905-51 | 58602090551 | 3 CONTAINER in 1 CARTON (58602-905-51) / 24 LOZENGE in 1 CONTAINER | 3 container | 2021-10-29 | No | No | Historical |
| 58602-905-52 | 58602090552 | 4 CONTAINER in 1 CARTON (58602-905-52) / 24 LOZENGE in 1 CONTAINER | 4 container | 2021-10-29 | No | No | Historical |
| 58602-905-65 | 58602090565 | 6 CONTAINER in 1 CARTON (58602-905-65) / 24 LOZENGE in 1 CONTAINER | 6 container | 2021-10-29 | No | No | Historical |