Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 55319-966
Nicotine 4 mg/1 · Gum, Chewing · Oral · Family Dollar (FAMILY WELLNESS)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-966-20 | 5531909662055319096620 | 20 BLISTER PACK in 1 CARTON (55319-966-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 1, 2023 |
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 — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Family Dollar (FAMILY WELLNESS)NDC labeler code 55319
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204833
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 55319-966_f4825c27-4253-4314-aa55-4d9819030f30SPL ID f4825c27-4253-4314-aa55-4d9819030f30SPL set ID d353b75f-3fc3-4958-92c6-08df6bdf283cRxCUI 311975UNII 6M3C89ZY6RUPC 0032251921056
- 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
N455319096620followed by a unit qualifier and the quantityPackage 55319-0966-20. 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 55319-966
- What is NDC 55319-966?
- 55319-966 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 gum, chewing, listed with the FDA by Family Dollar (FAMILY WELLNESS). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Polacrilex.
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Family Dollar (FAMILY WELLNESS), NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nicotine Polacrilex?
- 48 other product NDCs are listed under this name. See all Nicotine Polacrilex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Polacrilex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-927 | 72224-0927-10 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-924 | 72224-0924-10 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-925 | 72224-0925-10 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-933 | 72224-0933-10 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-976 | 55910-0976-20 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-927 | 84720-0927-03 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-933 | 84720-0933-03 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-796 | 55910-0796-20 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-933 | 55910-0933-10 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-8146 | 50090-8146-00 |
Other NDCs under ANDA 204833
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, ChewingOral | Walgreens | 0363-3290 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-933 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-293 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-449 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex gum | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-217 |
| Nicotine Polacrilex Coated Ice Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0344 |