Over-the-counter drug · ANDA
Rugby Nicotine Polacrilex Gum, Mint Flavor (Nicotine polacrilex) NDC 50090-3560
Nicotine 2 mg/1 · Gum, Chewing · Buccal · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3560-0 | 50090356000 | 11 BLISTER PACK in 1 CARTON (50090-3560-0) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Aug 29, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Rugby Nicotine Polacrilex Gum, Mint Flavor
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076569
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 50090-3560_8daba42e-328d-4a3a-a233-0b457e7aa7f7SPL ID 8daba42e-328d-4a3a-a233-0b457e7aa7f7SPL set ID 7b70162e-0087-466f-9b8b-8289b6e90e39RxCUI 314119UNII 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090356000followed by a unit qualifier and the quantityPackage 50090-3560-00. 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 50090-3560
- What is NDC 50090-3560?
- 50090-3560 is the product NDC for Rugby Nicotine Polacrilex Gum, Mint Flavor, Nicotine 2 mg/1 gum, chewing, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rugby Nicotine Polacrilex Gum, Mint Flavor (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rugby Nicotine Polacrilex Gum, Mint Flavor?
- 1 other product NDC are listed under this name. See all Rugby Nicotine Polacrilex Gum, Mint Flavor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rugby Nicotine Polacrilex Gum, Mint Flavor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rugby Nicotine Polacrilex Gum, Mint Flavornicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | ATLANTIC BIOLOGICALS CORP. | 17856-1362 | 17856-1362-01 |
Other NDCs under ANDA 076569
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 |
|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-1362 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-724 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Cardinal Health 107, LLC | 55154-6818 |
| Nicotine Polacrilex MINTnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-1420 |
| Rugby Nicotine Polacrilex Gum, Mint Flavornicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | ATLANTIC BIOLOGICALS CORP. | 17856-1362 |