Over-the-counter drug · ANDA
Nicotine Polacrilex coated mint (nicotine polacrilex) NDC 69842-428
Nicotine 2 mg/1 · Gum, Chewing · Buccal · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69842-428-16 | 69842042816 | 160 BLISTER PACK in 1 CARTON (69842-428-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-428-22 | 69842042822 | 120 BLISTER PACK in 1 CARTON (69842-428-22) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-428-79 | 69842042879 | 10 BLISTER PACK in 1 CARTON (69842-428-79) / 1 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
- CVS Pharmacy
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078699
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 69842-428_e42098ad-5498-4210-9046-0c1987640246SPL ID e42098ad-5498-4210-9046-0c1987640246SPL set ID 84daeb67-5982-4b9e-b56a-4cc6a223a3f8RxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0050428299210, 0050428398364
- 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
N469842042816followed by a unit qualifier and the quantityPackage 69842-0428-16. 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 | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-9270 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-927 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-428 |
| 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 |