Over-the-counter drug · ANDA
Nicotine (nicotine polacrilex) NDC 0536-3113
Nicotine 4 mg/1 · Gum, Chewing · Buccal · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-3113-01 | 00536311301 | 100 BLISTER PACK in 1 CARTON (0536-3113-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3113-25)Marketed from Dec 29, 2008 | |
| 0536-3113-37 | 00536311337 | 40 BLISTER PACK in 1 CARTON (0536-3113-37) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3113-25)Marketed from Dec 29, 2008 |
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)
- Nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0536-3113_2ea2f7a2-3d30-4cd5-bc15-1181050f1d63SPL ID 2ea2f7a2-3d30-4cd5-bc15-1181050f1d63SPL set ID 621eb214-0716-4306-829f-6185a77f24d5RxCUI 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
N400536311301followed by a unit qualifier and the quantityPackage 00536-3113-01. 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.
Other NDCs under ANDA 078697
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 | Quitine LLC | 84720-933 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-429 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-281 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-285 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-976 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-560 |
| Nicotine Polacrilex coated mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-430 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-718 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Rising Pharma Holdings, Inc. | 57237-323 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-933 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-429 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreens | 0363-9330 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-796 |
| Habitrol Nicotine Polacrilex Gum 4 mg Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 75907-303 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0343 |