Over-the-counter drug · ANDA
nicotine (nicotine polacrilex) NDC 45802-827
Nicotine 2 mg/1 · Gum, Chewing · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-827-25 | 45802082725 | 110 BLISTER PACK in 1 CARTON (45802-827-25) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 22, 2023 |
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
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206394
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 45802-827_0e7a9ab0-a964-4959-8edc-7399c972340dSPL ID 0e7a9ab0-a964-4959-8edc-7399c972340dSPL set ID f9759891-7d3d-4714-8f8b-92d0a499e52eRxCUI 314119UNII 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
N445802082725followed by a unit qualifier and the quantityPackage 45802-0827-25. 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 206394
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 |
|---|---|---|---|---|
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-460 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7269 |
| up and up uncoated mint nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Target Corporation | 82442-899 |
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8100 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Kroger Company | 30142-749 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7050 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer, Inc. | 79481-0755 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-6020 |
| Kirkland Signature Quit 2nicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-012 |
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-7063 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0269 |
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-711 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-209 |
| coated nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-110 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Kroger Company | 30142-208 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-811 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-269 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-012 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-292 |
| nictoine gumnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0904 |
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