Over-the-counter drug · ANDA
Nicotine (nicotine polacrilex) NDC 0536-1337
Nicotine 2 mg/1 · Lozenge · Oral · Rugby Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1337-09 | 00536133709 | 3 BOTTLE, PLASTIC in 1 BOX (0536-1337-09) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Sep 17, 2021 | |
| 0536-1337-35 | 00536133735 | 1 BOTTLE, PLASTIC in 1 BOX (0536-1337-35) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Sep 17, 2021 |
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 — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Rugby Laboratories, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209206
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0536-1337_09bfc71c-cebe-4d12-8c99-d5b2017f5a79SPL ID 09bfc71c-cebe-4d12-8c99-d5b2017f5a79SPL set ID 150faf42-491f-403b-869b-48edd431d1ccRxCUI 359817UNII 6M3C89ZY6RUPC 0305361337094
- 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
N400536133709followed by a unit qualifier and the quantityPackage 00536-1337-09. 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 209206
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 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-734 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3317 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-858 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0562 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0561 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1338 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-957 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-9570 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-9580 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-732 |