Over-the-counter drug · ANDA
Nicotine Mini (Nicotine polacrilex) NDC 0363-5770
Nicotine 4 mg/1 · Lozenge · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-5770-20 | 0036357702000363577020 | 1 BOTTLE, PLASTIC in 1 BOX (0363-5770-20) / 20 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 20, 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 MiniSuffix: Mini
- 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 210711
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-5770_faf865a9-e0b1-49ce-8e5b-2fc8ad581b72SPL ID faf865a9-e0b1-49ce-8e5b-2fc8ad581b72SPL set ID 06455f66-da8e-4be5-9069-6840f93d6d77RxCUI 359818UNII 6M3C89ZY6RUPC 0311917032528
- 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
N400363577020followed by a unit qualifier and the quantityPackage 00363-5770-20. 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 0363-5770
- What is NDC 0363-5770?
- 0363-5770 is the product NDC for Nicotine Mini (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Walgreens. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Mini (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 Nicotine Mini?
- 34 other product NDCs are listed under this name. See all Nicotine Mini NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Mini products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-789 | 72288-0789-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-739 | 72288-0739-14 |
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-797 | 72288-0797-14 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-375 | 72288-0375-0172288-0375-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-569 | 72288-0569-0172288-0569-0472288-0569-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-652 | 59726-0652-0459726-0652-27 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-979 | 83253-0979-1883253-0979-2783253-0979-72+1 more |
| nicotine mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-6011 | 00363-6011-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-7051 | 00363-7051-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | A-S Medication Solutions | 50090-8151 | 50090-8151-00 |
Other NDCs under ANDA 210711
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 | Walgreens | 0363-9780 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | P & L Development, LLC | 59726-650 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-652 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | HC Jones, Inc. | 83253-978 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-979 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-0979 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-5760 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-932 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-934 |