Topcare Nicotine
- Product NDC
- 36800-539
- 11-digit product format
- 368000539
- Labeler code
- 36800
- Product ID
- 36800-539_d8a7c0b8-ccf2-44e8-8041-f71ea7359ba2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA090711
- Marketing category
- ANDA
- Marketing start
- 2013-02-12
- 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
- Topcare 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 | 359818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-539-03 | Topcare Nicotine | 24 in 1 CONTAINER | LOZENGE | 24 | | 6 |
| 36800-539-05 | Topcare Nicotine | 3 in 1 CARTON | LOZENGE | 3 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-539 | TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20181130_99da90fa-00ff-4c62-91a2-1e434dadaf41.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 |
|---|
| 36800-539-03 | 36800053903 | 24 in 1 CONTAINER | | | | | | Historical |
| 36800-539-05 | 36800053905 | 3 CONTAINER in 1 CARTON (36800-539-05) / 24 LOZENGE in 1 CONTAINER (36800-539-03) | 3 container | 2013-02-12 | 0000-00-00 | No | No | Current |