Nicotine
- Product NDC
- 0363-4049
- 11-digit product format
- 003634049
- Labeler code
- 0363
- Product ID
- 0363-4049_8cd1928b-b6cc-425f-91ee-dde130ad3ebc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- ANDA077007
- Marketing category
- ANDA
- Marketing start
- 2024-03-12
- Substance
- NICOTINE
- Active strength
- 2 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
- Nicotine
- Listing expiration
- 2026-12-31
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 |
|---|
| 0363-4049-01 | Nicotine | 40 in 1 CONTAINER | LOZENGE | 40 | | 3 |
| 0363-4049-02 | Nicotine | 2 in 1 CARTON | LOZENGE | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-4049 | NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY] | 2 | Current NDC, 2 package rows | 20240504_af8fadbb-25a7-4ab7-a665-808e4b41978a.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 |
|---|
| 0363-4049-01 | 00363404901 | 40 in 1 CONTAINER | | | | | Historical |
| 0363-4049-02 | 00363404902 | 2 CONTAINER in 1 CARTON (0363-4049-02) / 40 LOZENGE in 1 CONTAINER (0363-4049-01) | 2 container | 2024-03-12 | No | No | Current |