Nicotine Polacrilex
- Product NDC
- 57237-322
- 11-digit product format
- 572370322
- Labeler code
- 57237
- Product ID
- 57237-322_86a71c33-cb93-4dac-9418-c3817ec65f76
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078699
- Marketing category
- ANDA
- Marketing start
- 2023-08-10
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 314119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-322-01 | Nicotine Polacrilex | 100 in 1 CARTON | GUM, CHEWING | 100 | | 3 |
| 57237-322-01 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 3 |
| 57237-322-11 | Nicotine Polacrilex | 110 in 1 CARTON | GUM, CHEWING | 110 | | 3 |
| 57237-322-11 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 3 |
| 57237-322-50 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 3 |
| 57237-322-50 | Nicotine Polacrilex | 50 in 1 CARTON | GUM, CHEWING | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-322 | NICOTINE POLACRILEX GUM, CHEWING [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 6 package rows | 20240828_a3f19365-d0d1-43ad-be15-48dc4320e361.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57237-322-01 | 57237032201 | 100 BLISTER PACK in 1 CARTON (57237-322-01) / 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2023-08-10 | No | No | Current |
| 57237-322-11 | 57237032211 | 110 BLISTER PACK in 1 CARTON (57237-322-11) / 1 GUM, CHEWING in 1 BLISTER PACK | 110 blister pack | 2025-12-08 | No | No | Current |
| 57237-322-50 | 57237032250 | 50 BLISTER PACK in 1 CARTON (57237-322-50) / 1 GUM, CHEWING in 1 BLISTER PACK | 50 blister pack | 2025-12-08 | No | No | Current |