quitine nicotine
- Product NDC
- 84720-854
- 11-digit product format
- 847200854
- Labeler code
- 84720
- Product ID
- 84720-854_cc5080b8-4000-4afa-bace-51fc53ccd1b0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- QUITINE LLC
- Application
- ANDA078546
- Marketing category
- ANDA
- Marketing start
- 2024-12-04
- 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
- quitine nicotine
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84720-854-70 | quitine nicotine | 240 in 1 CARTON | GUM, CHEWING | 240 | | 3 |
| 84720-854-70 | quitine nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84720-854 | QUITINE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUITINE LLC] | 2 | Current NDC, 2 package rows | 20241215_426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48.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 |
|---|
| 84720-854-70 | 84720085470 | 240 BLISTER PACK in 1 CARTON (84720-854-70) / 1 GUM, CHEWING in 1 BLISTER PACK | 240 blister pack | 2024-12-04 | No | No | Current |