nicotine
- Product NDC
- 21130-389
- 11-digit product format
- 211300389
- Labeler code
- 21130
- Product ID
- 21130-389_8003d699-4d8c-4c38-a7b7-3cfd1b20a536
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Safeway
- Application
- ANDA076775
- Marketing category
- ANDA
- Marketing start
- 2024-07-17
- 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 | 314119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21130-389-25 | nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 2 |
| 21130-389-25 | nicotine | 110 in 1 CARTON | GUM, CHEWING | 110 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-389 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAFEWAY] | 2 | Current NDC, 2 package rows | 20240724_ed4fe766-1329-4d57-894d-3b977dd07b5c.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 |
|---|
| 21130-389-25 | 21130038925 | 110 BLISTER PACK in 1 CARTON (21130-389-25) / 1 GUM, CHEWING in 1 BLISTER PACK | 110 blister pack | 2024-07-17 | No | No | Historical |