Over-the-counter drug · ANDA
Nicotine (nicotine polacrilex) NDC 11822-0905
Nicotine 4 mg/1 · Lozenge · Oral · Rite Aid Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-0905-4 | 11822090504 | 3 BOTTLE, PLASTIC in 1 BOX (11822-0905-4) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 1, 2020 | |
| 11822-0905-7 | 11822090507 | 1 BOTTLE, PLASTIC in 1 BOX (11822-0905-7) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 1, 2020 |
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
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Rite Aid Corporation
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212056
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 11822-0905_a5b861e0-8aeb-4cbd-897f-011f99d04299SPL ID a5b861e0-8aeb-4cbd-897f-011f99d04299SPL set ID 9f77adad-4b67-48c8-9ad4-24bccdea3ae2RxCUI 359818UNII 6M3C89ZY6RUPC 0011822090247
- 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
N411822090504followed by a unit qualifier and the quantityPackage 11822-0905-04. 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 212056
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.