Nicotine Polacrilex
- Product NDC
- 46122-449
- 11-digit product format
- 461220449
- Labeler code
- 46122
- Product ID
- 46122-449_9423d6f8-fad6-425c-83f0-773512ac28a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- AmerisourceBergen (Good Neighbor Pharmacy) 46122
- Application
- ANDA204833
- Marketing category
- ANDA
- Marketing start
- 2018-01-09
- 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 ice mint
- 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 |
|---|
| 46122-449-58 | Nicotine Polacrilexcoated ice mint | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 15 |
| 46122-449-58 | Nicotine Polacrilexcoated ice mint | 40 in 1 CARTON | GUM, CHEWING | 40 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-449 | NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241024_c21147f5-da96-424c-9058-24eb751b64ea.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 |
|---|
| 46122-449-58 | 46122044958 | 40 BLISTER PACK in 1 CARTON (46122-449-58) / 1 GUM, CHEWING in 1 BLISTER PACK | 40 blister pack | 2018-01-09 | 0000-00-00 | No | No | Current |