topcare nicotine
- Product NDC
- 76162-700
- 11-digit product format
- 761620700
- Labeler code
- 76162
- Product ID
- 76162-700_ca6eca25-9077-44c5-9ccf-e7f381107e84
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA077007
- Marketing category
- ANDA
- Marketing start
- 2023-06-08
- 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 |
|---|
| 76162-700-27 | 76162070027 | 2 CONTAINER in 1 CARTON (76162-700-27) / 40 LOZENGE in 1 CONTAINER | 2 container | 2023-06-08 | No | No | Historical |
| 76162-700-58 | 76162070058 | 40 LOZENGE in 1 CONTAINER (76162-700-58) | 40 lozenge | 2023-06-08 | No | No | Historical |