Over-the-counter drug · ANDA
Kirkland Signature Nicotine (Nicotine) NDC 63981-190
Nicotine 4 mg/1 · Lozenge · Oral · Costco Wholesale Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63981-190-37 | 6398101903763981019037 | 10 CONTAINER in 1 PACKAGE (63981-190-37) / 27 LOZENGE in 1 CONTAINERMarketed from May 8, 2020 |
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 Nicotine
- Generic name (nonproprietary)
- nicotine
- Active ingredients
- Nicotine — 4 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 090711
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 63981-190_b864361c-f31a-4bdf-b033-828f7f204f1eSPL ID b864361c-f31a-4bdf-b033-828f7f204f1eSPL set ID 0888a974-a8ba-4cb3-996f-c8abfcb90a6fRxCUI 359818UNII 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
N463981019037followed by a unit qualifier and the quantityPackage 63981-0190-37. 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 63981-190
- What is NDC 63981-190?
- 63981-190 is the product NDC for Kirkland Signature Nicotine (nicotine), Nicotine 4 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 Nicotine (Nicotine).
- 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 Nicotine?
- 1 other product NDC are listed under this name. See all Kirkland Signature Nicotine 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 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) |
|---|---|---|---|---|---|
| Kirkland Signature Nicotinenicotine | Nicotine 2 mg/1 | LozengeOral | Costco Wholesale Company | 63981-124 | 63981-0124-37 |
Other NDCs under ANDA 090711
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 | 72288-124 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-190 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-124 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-190 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-1125 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-1190 |
| Kirkland Signature Nicotinenicotine | Nicotine 2 mg/1 | LozengeOral | Costco Wholesale Company | 63981-124 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-0124 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-4190 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0009 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0124 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-124 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Kroger Company | 30142-190 |
| nicotine | Nicotine 4 mg/1 | LozengeOral | H E B | 37808-383 |
| nicotine | Nicotine 2 mg/1 | LozengeOral | H E B | 37808-533 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-700 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-499 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-509 |
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