Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 45802-957
Nicotine 4 mg/1 · Lozenge · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-957-02 | 45802095702 | 3 CONTAINER in 1 CARTON (45802-957-02) / 27 LOZENGE in 1 CONTAINER (45802-957-01)Marketed from Jul 8, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nicotine Polacrilex
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203690
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 45802-957_b914d574-91d6-4fb4-920a-6794f7cefe96SPL ID b914d574-91d6-4fb4-920a-6794f7cefe96SPL set ID f6cc8d50-2d8d-4ed4-930a-a2479b1ebffeRxCUI 359818UNII 6M3C89ZY6R
- Pharmacologic class
- Cholinergic Nicotinic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N445802095702followed by a unit qualifier and the quantityPackage 45802-0957-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203690
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Kroger Company | 30142-797 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-696 |
| up and up nicotine mini mintnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Target Corporation | 82442-957 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-642 |
| Rexall Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp, LLC | 55910-957 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-060 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-734 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-7051 |
| mini nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer, Inc. | 79481-0734 |
| exchange select nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-734 |
| nicotine mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-6011 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-739 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-077 |
| CareOne Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-734 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-734 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer, Inc. | 79481-0957 |
| exchange select nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-957 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-734 |
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-797 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-808 |
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