Over-the-counter drug · ANDA
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor (Nicotine polacrilex) NDC 0536-3386
Nicotine 2 mg/1 · Gum, Chewing · Buccal · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-3386-01 | 0053633860100536338601 | 10 BLISTER PACK in 1 CARTON (0536-3386-01) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 8, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- Rugby LaboratoriesNDC labeler code 0536
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079044
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0536-3386_c3233d63-7235-4d38-bea1-e0f2d0fe9cd1SPL ID c3233d63-7235-4d38-bea1-e0f2d0fe9cd1SPL set ID b973d045-7791-49c1-9216-4e0d51173735RxCUI 311975, 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
N400536338601followed by a unit qualifier and the quantityPackage 00536-3386-01. 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 0536-3386
- What is NDC 0536-3386?
- 0536-3386 is the product NDC for Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor, Nicotine 2 mg/1 gum, chewing, listed with the FDA by Rugby Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Rugby Laboratories, NDC labeler code 0536. 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, Coated Fruit Flavor?
- 1 other product NDC are listed under this name. See all Rugby Nicotine Polacrilex Gum, Coated Fruit 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, Coated Fruit 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, Coated Fruit Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3387 | 00536-3387-01 |
Other NDCs under ANDA 079044
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 |
|---|---|---|---|---|
| Habitrol Nicotine Polacrilex Gum 2 mg Coated Fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 75907-301 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-9250 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | P & L Development, LLC | 59726-592 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-503 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-925 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-503 |
| Nicotine Polacrilex coated fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-024 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0346 |