Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 84720-927
Nicotine 2 mg/1 · Gum, Chewing · Oral · Quitine LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84720-927-03 | 84720092703 | 300 BLISTER PACK in 1 CARTON (84720-927-03) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 15, 2024 |
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 — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Quitine LLC
- 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 84720-927_272263eb-fe23-42e9-bfa1-41b860133a40SPL ID 272263eb-fe23-42e9-bfa1-41b860133a40SPL set ID 9e46b967-1668-42a7-be87-225ded849395RxCUI 314119UNII 6M3C89ZY6RUPC 0359726927307
- 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
N484720092703followed by a unit qualifier and the quantityPackage 84720-0927-03. 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, 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 |
| 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 |