Nicotine Polacrilex
- Product NDC
- 55301-503
- 11-digit product format
- 553010503
- Labeler code
- 55301
- Product ID
- 55301-503_f9506509-28e9-490f-88db-7ca4823ca731
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- AAFES/Your Military Exchanges
- Application
- ANDA079044
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Substance
- NICOTINE
- Active strength
- 2 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 2 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 |
|---|
| 55301-503-44 | Nicotine Polacrilex | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 16 |
| 55301-503-44 | Nicotine Polacrilex | 100 in 1 CARTON | GUM, CHEWING | 100 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55301-503 | NICOTINE POLACRILEX GUM, CHEWING [AAFES/YOUR MILITARY EXCHANGES] | 15 | Current NDC, Legacy NDC, 2 package rows | 20250510_6d895db2-7423-42bc-ae78-e0b47189e2d2.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 |
|---|
| 55301-503-44 | 55301050344 | 100 BLISTER PACK in 1 CARTON (55301-503-44) / 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2014-01-01 | 0000-00-00 | No | No | Current |