Over-the-counter drug · ANDA
Nicotine (nicotine polacrilex) NDC 0363-9620
Nicotine 4 mg/1 · Lozenge · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9620-24 | 00363962024 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9620-24) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Jan 31, 2021 | |
| 0363-9620-72 | 00363962072 | 3 BOTTLE, PLASTIC in 1 BOX (0363-9620-72) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Jan 31, 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 — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Walgreens
- 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 0363-9620_8501db70-44e0-4269-8a01-1933283a6ed1SPL ID 8501db70-44e0-4269-8a01-1933283a6ed1SPL set ID 97ce52b1-d98e-4216-99c2-7e341c8fec43RxCUI 359818UNII 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
N400363962024followed by a unit qualifier and the quantityPackage 00363-9620-24. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212056
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.