Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 0363-4098
Nicotine 4 mg/1 · Lozenge · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-4098Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-4098Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-4098-27 | 0036340982700363409827 | 2 CONTAINER in 1 CARTON (0363-4098-27) / 40 LOZENGE in 1 CONTAINER (0363-4098-40)Marketed from Aug 14, 2026 |
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
- Walgreen CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077007
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-4098_8cd94ea1-868d-4981-af75-bb182cddd73cSPL ID 8cd94ea1-868d-4981-af75-bb182cddd73c
- 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
N400363409827followed by a unit qualifier and the quantityPackage 00363-4098-27. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0363-4098
- What is NDC 0363-4098?
- 0363-4098 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Walgreen Company, 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?
- 197 other product NDCs are listed under this name. See all Nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-684 | 72288-0684-02 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-730 | 72288-0730-60 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-755 | 72288-0755-06 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 | 72288-0863-06 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-772 | 21130-0772-02 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-969 | 72288-0969-76 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-869 | 72288-0869-76 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Cardinal Health 107, LLC | 55154-6818 | 55154-6818-00 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-651 | 72288-0651-14 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-2511 | 00363-2511-27 |
Other NDCs under ANDA 077007
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 4 mg/1 | LozengeOral | Kroger Company | 30142-873 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sixarp, LLC | 59368-463 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-492 |
| exchange select nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-617 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-509 |
| up and up nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Target Corporation | 82442-741 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L Perrigo Company | 0113-6099 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Safeway | 21130-636 |
| exchange select nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-873 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-344 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 59779-344 |
| up and up mint nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Target Corporation | 82442-873 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | LozengeOral | A-S Medication Solutions | 50090-1152 |
| quitine nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | QUITINE LLC | 84720-007 |
| signature care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-700 |
| kirkland signature quit 2nicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Costco Wholesale Company | 63981-344 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | A-S Medication Solutions | 50090-1154 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-319 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | H E B | 59640-099 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | H E B | 59640-151 |
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