Over-the-counter drug · ANDA
nicotine (Nicotine polacrilex) NDC 0363-1825
Nicotine 2 mg/1 · Lozenge · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-1825Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-1825Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1825-07 | 00363182507 | 3 CONTAINER in 1 CARTON (0363-1825-07) / 27 LOZENGE in 1 CONTAINERMarketed from Nov 8, 2018 | |
| 0363-1825-09 | 00363182509 | 27 LOZENGE in 1 CONTAINER (0363-1825-09)Marketed from Nov 8, 2018 | |
| 0363-1825-60 | 00363182560 | 1 CONTAINER in 1 CARTON (0363-1825-60) / 20 LOZENGE in 1 CONTAINERMarketed from Nov 8, 2018 |
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 — 2 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 203690
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-1825_ee4e4e2b-9f71-4e03-a214-ffcaa9e0e78eSPL ID ee4e4e2b-9f71-4e03-a214-ffcaa9e0e78eSPL set ID 8af06c23-80b7-4559-b594-a3a02297306dRxCUI 359817UNII 6M3C89ZY6RUPC 0012345678905
- 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
N400363182507followed by a unit qualifier and the quantityPackage 00363-1825-07. 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 0363-1825
- What is NDC 0363-1825?
- 0363-1825 is the product NDC for nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by Walgreen Company. It has 3 package NDCs, 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?
- 194 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 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 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sixarp, LLC | 59368-463 | 59368-0463-02 |
Other NDCs under ANDA 203690
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 |
|---|---|---|---|---|
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-077 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-223 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-642 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-734 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-808 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-957 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-734 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | BJWC | 68391-957 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Blip Products, Inc. | 82966-222 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Blip Products, Inc. | 82966-303 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Blip Products, Inc. | 82966-734 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Blip Products, Inc. | 82966-957 |
| CareOne Mini Nicotine Polacrilexnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | American Sales Company | 41520-957 |
| CareOne Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-734 |
| Dg Health Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp Inc | 55910-669 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-734 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-791 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-900 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-104 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-160 |
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