Nicotine
- Product NDC
- 59726-592
- 11-digit product format
- 597260592
- Labeler code
- 59726
- Product ID
- 59726-592_1c0152ef-e9c9-44c4-a750-b08052a1ce07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- P & L Development, LLC
- Application
- ANDA079044
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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
- 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 | 314119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59726-592-16 | Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 4 |
| 59726-592-16 | Nicotine | 160 in 1 CARTON | GUM, CHEWING | 160 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59726-592 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [P & L DEVELOPMENT, LLC] | 2 | Current NDC, 2 package rows | 20240710_ac252ff2-b4a8-4be2-9ec8-08f76c8ab908.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59726-592-16 | 59726059216 | 160 BLISTER PACK in 1 CARTON (59726-592-16) / 1 GUM, CHEWING in 1 BLISTER PACK | 160 blister pack | 2024-03-01 | No | No | Historical |