Topcare Nicotine
- Product NDC
- 36800-650
- 11-digit product format
- 368000650
- Labeler code
- 36800
- Product ID
- 36800-650_f8f587ff-e8de-4d5b-ac9d-812ba09bfd41
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA206393
- Marketing category
- ANDA
- Marketing start
- 2017-02-13
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topcare Nicotine
- Listing expiration
- 2026-12-31
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 |
|---|
| 36800-650-60 | Topcare Nicotine | 20 in 1 CARTON | GUM, CHEWING | 20 | | 5 |
| 36800-650-60 | Topcare Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 5 |
| 36800-650-78 | Topcare Nicotine | 100 in 1 CARTON | GUM, CHEWING | 100 | | 5 |
| 36800-650-78 | Topcare Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-650 | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250315_03d9708a-923c-4fd3-ac3d-6ab4a4d8a804.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 |
|---|
| 36800-650-60 | 36800065060 | 20 BLISTER PACK in 1 CARTON (36800-650-60) / 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2017-02-13 | 0000-00-00 | No | No | Current |
| 36800-650-78 | 36800065078 | 100 BLISTER PACK in 1 CARTON (36800-650-78) / 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2017-02-13 | 0000-00-00 | No | No | Current |