Nicotine Polacrilex
- Product NDC
- 68016-293
- 11-digit product format
- 680160293
- Labeler code
- 68016
- Product ID
- 68016-293_692c9f96-0fb8-4d22-908b-4ffbff764fb0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- ANDA204833
- Marketing category
- ANDA
- Marketing start
- 2017-10-01
- Marketing end
- 2027-02-28
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
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 |
|---|
| 68016-293-44 | Nicotine Polacrilex | 100 in 1 CARTON | GUM, CHEWING | 100 | | 10 |
| 68016-293-44 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-293 | NICOTINE POLACRILEX GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20221122_9c115cd5-1952-4f1e-8e88-27f2c528e91f.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 |
|---|
| 68016-293-44 | 68016029344 | 100 BLISTER PACK in 1 CARTON (68016-293-44) / 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2017-10-01 | 2027-02-28 | No | No | Current |