Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 0363-9590
Nicotine 2 mg/1 · Lozenge · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9590-08 | 00363959008 | 4 BOTTLE, PLASTIC in 1 BOX (0363-9590-08) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021 | |
| 0363-9590-24 | 00363959024 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9590-24) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021 | |
| 0363-9590-27 | 00363959027 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9590-27) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021 | |
| 0363-9590-72 | 00363959072 | 3 BOTTLE, PLASTIC in 1 BOX (0363-9590-72) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 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 — 2 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 0363-9590_22be9a90-9024-43fc-a56d-eacb6f29a310SPL ID 22be9a90-9024-43fc-a56d-eacb6f29a310SPL set ID 0135caa0-f5e9-471e-ac5f-6b9be8ddfcb0RxCUI 359817UNII 6M3C89ZY6RUPC 0311917220666
- 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
N400363959008followed by a unit qualifier and the quantityPackage 00363-9590-08. 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 0363-9590
- What is NDC 0363-9590?
- 0363-9590 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 2 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?
- 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 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 210712
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 |
|---|---|---|---|---|
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-0960 |