CareOne Nicotine
- Product NDC
- 41520-734
- 11-digit product format
- 415200734
- Labeler code
- 41520
- Product ID
- 41520-734_220bbce6-322b-4f00-95e5-d2499062cd07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA203690
- Marketing category
- ANDA
- Marketing start
- 2013-06-28
- 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
- CareOne 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 | 359817 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41520-734-01 | CareOne Nicotine | 27 in 1 CONTAINER | LOZENGE | 27 | | 6 |
| 41520-734-02 | CareOne Nicotine | 3 in 1 CARTON | LOZENGE | 3 | | 6 |
| 41520-734-03 | CareOne Nicotine | 4 in 1 CARTON | LOZENGE | 4 | | 6 |
| 41520-734-03 | CareOne Nicotine | 27 in 1 CONTAINER | LOZENGE | 27 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-734 | CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY] | 5 | Current NDC, Legacy NDC, 4 package rows | 20231026_74ec6a60-eb3a-47d4-a11b-650b6418d37f.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 |
|---|
| 41520-734-01 | 41520073401 | 27 in 1 CONTAINER | | | | | | Historical |
| 41520-734-02 | 41520073402 | 3 CONTAINER in 1 CARTON (41520-734-02) / 27 LOZENGE in 1 CONTAINER (41520-734-01) | 3 container | 2013-08-07 | 0000-00-00 | No | No | Current |
| 41520-734-03 | 41520073403 | 4 CONTAINER in 1 CARTON (41520-734-03) > 27 LOZENGE in 1 CONTAINER | 4 container | 2013-06-28 | 0000-00-00 | No | No | Current |