Nicotine Polacrilex
- Product NDC
- 84720-933
- 11-digit product format
- 847200933
- Labeler code
- 84720
- Product ID
- 84720-933_12db9b11-b611-447b-9bab-e18fca6cdb3a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Quitine LLC
- Application
- ANDA078697
- Marketing category
- ANDA
- Marketing start
- 2024-12-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 311975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84720-933-03 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 2 |
| 84720-933-03 | Nicotine Polacrilex | 300 in 1 CARTON | GUM, CHEWING | 300 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84720-933 | NICOTINE POLACRILEX GUM, CHEWING [QUITINE LLC] | 2 | Current NDC, 2 package rows | 20241219_dc142c50-5310-43f5-a9e5-e174116685f8.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 |
|---|
| 84720-933-03 | 84720093303 | 300 BLISTER PACK in 1 CARTON (84720-933-03) / 1 GUM, CHEWING in 1 BLISTER PACK | 300 blister pack | 2024-12-15 | No | No | Current |