Over-the-counter drug · ANDA
Nicotine Polacrilex coated fruit (nicotine polacrilex) NDC 69842-025
Nicotine 4 mg/1 · Gum, Chewing · Buccal · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69842-025-15 | 69842002515 | 20 BLISTER PACK in 1 CARTON (69842-025-15) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-025-16 | 69842002516 | 160 BLISTER PACK in 1 CARTON (69842-025-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-025-44 | 69842002544 | 100 BLISTER PACK in 1 CARTON (69842-025-44) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-025-79 | 69842002579 | 10 BLISTER PACK in 1 CARTON (69842-025-79) / 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 fruitSuffix: coated fruit
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 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 079038
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 69842-025_100ca279-eb96-4ad3-b1f4-ff7037b7306dSPL ID 100ca279-eb96-4ad3-b1f4-ff7037b7306dSPL set ID 8c5e99d7-9d2d-488b-a804-496edafd30cfRxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0050428326275
- 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
N469842002515followed by a unit qualifier and the quantityPackage 69842-0025-15. 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 079038
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 4 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-504 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-931 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreens | 0363-9310 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-504 |
| Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 75907-300 |
| Rugby Nicotine Polacrilex Gum, Coated Fruit Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3387 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0342 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | P & L Development, LLC | 59726-913 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-918 |