Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 72162-2266
Nicotine 2 mg/1 · Lozenge · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2266-2 | 72162226602 | 3 BOTTLE in 1 CARTON (72162-2266-2) / 24 LOZENGE in 1 BOTTLEMarketed from Aug 14, 2024 |
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)
- Nicotine Polacrilex
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212796
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 72162-2266_79ad3f96-2578-45bb-a8dc-e8afff8c91b5SPL ID 79ad3f96-2578-45bb-a8dc-e8afff8c91b5SPL set ID b2f4506b-b575-4ed8-b10b-935451ea3451RxCUI 359817UNII 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
N472162226602followed by a unit qualifier and the quantityPackage 72162-2266-02. 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 212796
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 Lozenge Mintnicotine polacrilex lozenge 2 mg | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-986 |
| Habitrol Nicotine Polacrilex Lozenge Mintnicotine polacrilex lozenge 4 mg | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-987 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-487 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-486 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Bryant Ranch Prepack | 72162-2267 |