Nicotine Polacrilex
- Product NDC
- 68071-3957
- 11-digit product format
- 680713957
- Labeler code
- 68071
- Product ID
- 68071-3957_49617fc9-4948-7bab-e063-6294a90afcbb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA077007
- Marketing category
- ANDA
- Marketing start
- 2014-03-31
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3957-7 | Nicotine Polacrilex | 72 in 1 CONTAINER | LOZENGE | 72 | | 2 |
| 68071-3957-7 | Nicotine Polacrilex | 3 in 1 CARTON | LOZENGE | 3 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3957-7 | 68071395707 | 3 CONTAINER in 1 CARTON (68071-3957-7) / 72 LOZENGE in 1 CONTAINER | 3 container | 2026-01-23 | No | No | Historical |