Nicotine Polacrilex
- Product NDC
- 0363-1609
- 11-digit product format
- 003631609
- Labeler code
- 0363
- Product ID
- 0363-1609_ce202975-a51b-43ae-aec6-d64f38f1be16
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- Walgreens
- Application
- ANDA074707
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- original
- 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 |
|---|
| 0363-1609-62 | Nicotine Polacrilexoriginal | 110 in 1 CARTON | GUM, CHEWING | 110 | | 12 |
| 0363-1609-62 | Nicotine Polacrilexoriginal | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 12 |
| 0363-1609-98 | Nicotine Polacrilexoriginal | 170 in 1 CARTON | GUM, CHEWING | 170 | | 12 |
| 0363-1609-98 | Nicotine Polacrilexoriginal | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-1609 | NICOTINE POLACRILEX ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241018_f759d9b2-35e0-4b88-9219-4c0e483af5c4.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 |
|---|
| 0363-1609-62 | 00363160962 | 110 BLISTER PACK in 1 CARTON (0363-1609-62) / 1 GUM, CHEWING in 1 BLISTER PACK | 110 blister pack | 2014-01-01 | 0000-00-00 | No | No | Current |
| 0363-1609-98 | 00363160998 | 170 BLISTER PACK in 1 CARTON (0363-1609-98) / 1 GUM, CHEWING in 1 BLISTER PACK | 170 blister pack | 2014-01-01 | 0000-00-00 | No | No | Current |