Nicotine Polacrilex
- Product NDC
- 55319-966
- 11-digit product format
- 553190966
- Labeler code
- 55319
- Product ID
- 55319-966_f4825c27-4253-4314-aa55-4d9819030f30
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- ANDA204833
- Marketing category
- ANDA
- Marketing start
- 2023-07-01
- Marketing end
- 2028-03-28
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55319-966-20 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 7 |
| 55319-966-20 | Nicotine Polacrilex | 20 in 1 CARTON | GUM, CHEWING | 20 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-966 | NICOTINE POLACRILEX GUM, CHEWING [FAMILY DOLLAR (FAMILY WELLNESS)] | 4 | Current NDC, 2 package rows | 20240829_d353b75f-3fc3-4958-92c6-08df6bdf283c.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 |
|---|
| 55319-966-20 | 55319096620 | 20 BLISTER PACK in 1 CARTON (55319-966-20) / 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2023-07-01 | 2028-03-28 | No | No | Historical |