NICOTINE
- Product NDC
- 58602-903
- 11-digit product format
- 586020903
- Labeler code
- 58602
- Product ID
- 58602-903_dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA213266
- Marketing category
- ANDA
- Marketing start
- 2022-06-24
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-903 | NICOTINE (NICOTINE POLACRILEX) LOZENGE [AUROHEALTH LLC] | 1 | Current NDC, Legacy NDC, 6 package rows | 20220626_dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa.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 |
|---|
| 58602-903-07 | 58602090307 | 1 CONTAINER in 1 CARTON (58602-903-07) / 24 LOZENGE in 1 CONTAINER | 1 container | 2022-06-24 | 0000-00-00 | No | No | Current |
| 58602-903-51 | 58602090351 | 3 CONTAINER in 1 CARTON (58602-903-51) / 24 LOZENGE in 1 CONTAINER | 3 container | 2022-06-24 | 0000-00-00 | No | No | Current |
| 58602-903-65 | 58602090365 | 6 CONTAINER in 1 CARTON (58602-903-65) / 24 LOZENGE in 1 CONTAINER | 6 container | 2022-06-24 | 0000-00-00 | No | No | Current |