Over-the-counter drug · ANDA
quitine nicotine (Nicotine polacrilex) NDC 84720-854
Nicotine 4 mg/1 · Gum, Chewing · Oral · QUITINE LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84720-854-70 | 8472008547084720085470 | 240 BLISTER PACK in 1 CARTON (84720-854-70) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 4, 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)
- quitine nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- QUITINE LLCNDC labeler code 84720
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078546
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 84720-854_cc5080b8-4000-4afa-bace-51fc53ccd1b0SPL ID cc5080b8-4000-4afa-bace-51fc53ccd1b0SPL set ID 426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48RxCUI 311975UNII 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
N484720085470followed by a unit qualifier and the quantityPackage 84720-0854-70. 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.
About NDC 84720-854
- What is NDC 84720-854?
- 84720-854 is the product NDC for quitine nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by QUITINE LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- quitine nicotine (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- QUITINE LLC, NDC labeler code 84720. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for quitine nicotine?
- 13 other product NDCs are listed under this name. See all quitine nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other quitine nicotine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| quitine nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-103 | 84720-0103-70 |
| Quitine Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-755 | 84720-0755-70 |
| Quitine Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | QUITINE LLC | 84720-222 | 84720-0222-76 |
| Quitine Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-012 | 84720-0012-70 |
| Quitine Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-309 | 84720-0309-70 |
| Quitine Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | QUITINE LLC | 84720-400 | 84720-0400-76 |
| Quitine nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | QUITINE LLC | 84720-124 | 84720-0124-11 |
| Quitine Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | QUITINE LLC | 84720-190 | 84720-0190-11 |
| quitine nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | QUITINE LLC | 84720-000 | 84720-0000-76 |
| quitine nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | QUITINE LLC | 84720-007 | 84720-0007-76 |
Other NDCs under ANDA 078546
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 |
|---|---|---|---|---|
| Care One Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-854 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-854 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1165 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0854 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-854 |