Over-the-counter drug · ANDA
Nicotine Polacrilex Coated Mint (nicotine polacrilex) NDC 56062-428
Nicotine 2 mg/1 · Gum, Chewing · Buccal · Publix Supermarkets, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 56062-428-44 | 56062042844 | 10 BLISTER PACK in 1 CARTON (56062-428-44) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 |
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 Coated MintSuffix: Coated Mint
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- Publix Supermarkets, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078699
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 56062-428_beb2e867-a0cc-433c-82ed-3c191075049dSPL ID beb2e867-a0cc-433c-82ed-3c191075049dSPL set ID a6ef9fd0-9706-4924-b7f5-e2562b9d99e0RxCUI 311975, 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N456062042844followed by a unit qualifier and the quantityPackage 56062-0428-44. 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 078699
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 |
|---|---|---|---|---|
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-717 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Rising Pharma Holdings, Inc. | 57237-322 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0347 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-927 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-428 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-280 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-284 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-559 |
| Nicotine Polacrilex coated mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-428 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-9270 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-927 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3112 |
| Habitrol Nicotine Polacrilex Gum 2 mg Coated Mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Dr. Reddy's Laboratories Inc. | 75907-302 |