NICOTINE
- Product NDC
- 51316-190
- 11-digit product format
- 513160190
- Labeler code
- 51316
- Product ID
- 51316-190_6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- ANDA090711
- Marketing category
- ANDA
- Marketing start
- 2024-06-19
- 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
- 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 | 359818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-190-09 | NICOTINE | 27 in 1 CONTAINER | LOZENGE | 27 | | 2 |
| 51316-190-10 | NICOTINE | 4 in 1 CARTON | LOZENGE | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-190 | NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] | 2 | Current NDC, 2 package rows | 20240709_114418c4-6f39-46ce-912c-ac3687b7b75e.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 |
|---|
| 51316-190-09 | 51316019009 | 27 in 1 CONTAINER | | | | | Historical |
| 51316-190-10 | 51316019010 | 4 CONTAINER in 1 CARTON (51316-190-10) / 27 LOZENGE in 1 CONTAINER (51316-190-09) | 4 container | 2024-06-19 | No | No | Current |