Over-the-counter drug · ANDA
Maxi Nicotine (Nicotine polacrilex) NDC 0363-0960
Nicotine 4 mg/1 · Lozenge · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0960-08 | 0036309600800363096008 | 4 BOTTLE, PLASTIC in 1 BOX (0363-0960-08) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Oct 30, 2020 | |
| 0363-0960-24 | 0036309602400363096024 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0960-24) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Oct 30, 2020 | |
| 0363-0960-27 | 0036309602700363096027 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0960-27) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Oct 30, 2020 | |
| 0363-0960-72 | 0036309607200363096072 | 3 BOTTLE, PLASTIC in 1 BOX (0363-0960-72) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Oct 30, 2020 |
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)
- Maxi Nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- WalgreensNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210712
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-0960_fc34920e-93d7-40e0-803c-ad0a5f8e4060SPL ID fc34920e-93d7-40e0-803c-ad0a5f8e4060SPL set ID 7a25d940-6aca-47fe-9c77-babef21a4c80RxCUI 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
N400363096008followed by a unit qualifier and the quantityPackage 00363-0960-08. 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.
About NDC 0363-0960
- What is NDC 0363-0960?
- 0363-0960 is the product NDC for Maxi Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Walgreens. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Maxi Nicotine (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Maxi Nicotine?
- 3 other product NDCs are listed under this name. See all Maxi Nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Maxi Nicotine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1338 | 00536-1338-0900536-1338-35 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0561 | 70000-0561-01 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3317 | 11822-3317-0011822-3317-01 |
Other NDCs under ANDA 210712
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.