Nicotine Polacrilex
- Product NDC
- 70000-0342
- 11-digit product format
- 700000342
- Labeler code
- 70000
- Product ID
- 70000-0342_8d31f88b-5a5c-4552-b2f8-0e44600c8594
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000
- Application
- ANDA079038
- Marketing category
- ANDA
- Marketing start
- 2018-07-03
- 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
- Brand name suffix
- Coated Fruit
- 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 | 311975, 314119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0342-1 | Nicotine PolacrilexCoated Fruit | 20 in 1 CARTON | GUM, CHEWING | 20 | | 20 |
| 70000-0342-1 | Nicotine PolacrilexCoated Fruit | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0342 | NICOTINE POLACRILEX COATED FRUIT (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000] | 16 | Current NDC, Legacy NDC, 2 package rows | 20241116_d6c7a2ab-109d-40df-bce0-30c3531eb982.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70000-0342-1 | 70000034201 | 20 BLISTER PACK in 1 CARTON (70000-0342-1) / 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2018-07-03 | 0000-00-00 | No | No | Current |