Nicotine
- Product NDC
- 63548-0262
- 11-digit product format
- 635480262
- Labeler code
- 63548
- Product ID
- 63548-0262_096f4324-c2f9-4fa7-9e59-59396cf31149
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- PLD Acquisitions LLC DBA Av�ma Pharma Solutions
- Application
- ANDA207868
- Marketing category
- ANDA
- Marketing start
- 2019-04-01
- 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
- Brand name suffix
- Mini
- 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, 359818 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63548-0262-0 | NicotineMini | 4 in 1 BOX | LOZENGE | 4 | | 7 |
| 63548-0262-0 | NicotineMini | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 7 |
| 63548-0262-1 | NicotineMini | 3 in 1 BOX | LOZENGE | 3 | | 7 |
| 63548-0262-1 | NicotineMini | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 7 |
| 63548-0262-7 | NicotineMini | 1 in 1 BOX | LOZENGE | 1 | | 7 |
| 63548-0262-7 | NicotineMini | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63548-0262 | NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS] | 7 | Current NDC, Legacy NDC, 6 package rows | 20250330_71db232e-b169-47d0-b269-5e14fa75f3a2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63548-0262-0 | 63548026200 | 4 BOTTLE, PLASTIC in 1 BOX (63548-0262-0) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-04-01 | 0000-00-00 | No | No | Current |
| 63548-0262-1 | 63548026201 | 3 BOTTLE, PLASTIC in 1 BOX (63548-0262-1) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-04-01 | 0000-00-00 | No | No | Current |
| 63548-0262-7 | 63548026207 | 1 BOTTLE, PLASTIC in 1 BOX (63548-0262-7) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-04-01 | 0000-00-00 | No | No | Current |