Nicotine Polacrilex
- Product NDC
- 71335-2730
- 11-digit product format
- 713352730
- Labeler code
- 71335
- Product ID
- 71335-2730_5189572b-3c8e-403b-b2bc-132963a86981
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203690
- Marketing category
- ANDA
- Marketing start
- 2016-07-08
- 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
openFDA Listing Details
- Product ID
- 71335-2730_5189572b-3c8e-403b-b2bc-132963a86981
- SPL ID
- 5189572b-3c8e-403b-b2bc-132963a86981
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Generic name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Marketing start
- 2016-07-08
- Marketing category
- ANDA
- Application number
- ANDA203690
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC]; Nicotine [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359818 |
| Spl Set Id | 16ece78d-c66e-43c1-953a-f774797ae097 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2730-1 | 3 CONTAINER in 1 CARTON (71335-2730-1) / 27 LOZENGE in 1 CONTAINER | 2025-07-30 | No |
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 |
|---|
| 71335-2730-1 | 71335273001 | 3 CONTAINER in 1 CARTON (71335-2730-1) / 27 LOZENGE in 1 CONTAINER | 3 container | 2025-07-30 | No | No | Historical |