Over-the-counter drug · ANDA
kirkland signature quit 2 (Nicotine polacrilex) NDC 63981-344
Nicotine 2 mg/1 · Lozenge · Oral · Costco Wholesale Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63981-344-37 | 6398103443763981034437 | 10 CONTAINER in 1 PACKAGE (63981-344-37) / 27 LOZENGE in 1 CONTAINER (63981-344-09)Marketed from Sep 12, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- kirkland signature quit 2
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Costco Wholesale CompanyNDC labeler code 63981
- 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 63981-344_d3e32857-a3d2-42b7-a288-f395687f7f28SPL ID d3e32857-a3d2-42b7-a288-f395687f7f28SPL set ID cb462e10-124e-4ea3-9261-8c1fc7a9e1a6RxCUI 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
N463981034437followed by a unit qualifier and the quantityPackage 63981-0344-37. 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 63981-344
- What is NDC 63981-344?
- 63981-344 is the product NDC for kirkland signature quit 2 (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by Costco Wholesale Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- kirkland signature quit 2 (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Costco Wholesale Company, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for kirkland signature quit 2?
- 2 other product NDCs are listed under this name. See all kirkland signature quit 2 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other kirkland signature quit 2 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kirkland Signature Quit 2nicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-012 | 63981-0012-4763981-0012-87 |
| kirkland signature quit 2nicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-029 | 63981-0029-0163981-0029-56 |
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 |
|---|---|---|---|---|
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-344 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-492 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-509 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-873 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-344 |
| berkley and jensen nicotine polacrilexnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | BJWC | 68391-873 |
| care one nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | American Sales Company | 41520-873 |
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-701 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-873 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-998 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-182 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-353 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-354 |
| euqate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-101 |
| exchange select nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-617 |
| exchange select nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-873 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Strategic Sourcing Services LLC | 70677-1176 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Strategic Sourcing Services LLC | 70677-1177 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-0344 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-0873 |
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