Topcare Nicotine
- Product NDC
- 36800-734
- 11-digit product format
- 368000734
- Labeler code
- 36800
- Product ID
- 36800-734_cfed4776-31f3-4047-86af-67c2cb6fa16e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA203690
- Marketing category
- ANDA
- Marketing start
- 2013-02-15
- 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
- Topcare 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-734-01 | Topcare Nicotine | 27 in 1 CONTAINER | LOZENGE | 27 | | 6 |
| 36800-734-02 | Topcare Nicotine | 3 in 1 CARTON | LOZENGE | 3 | | 6 |
| 36800-734-04 | Topcare Nicotine | 5 in 1 CARTON | LOZENGE | 5 | | 6 |
| 36800-734-04 | Topcare 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 |
|---|
| 36800-734 | TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20211117_17cf8f3d-6491-4cd8-a447-3c7533f76daf.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 |
|---|
| 36800-734-01 | 36800073401 | 27 in 1 CONTAINER | | | | | | Historical |
| 36800-734-02 | 36800073402 | 3 CONTAINER in 1 CARTON (36800-734-02) / 27 LOZENGE in 1 CONTAINER (36800-734-01) | 3 container | 2013-02-15 | 0000-00-00 | No | No | Current |
| 36800-734-04 | 36800073404 | 5 CONTAINER in 1 CARTON (36800-734-04) > 27 LOZENGE in 1 CONTAINER | 5 container | 2014-06-15 | 0000-00-00 | No | No | Current |