Over-the-counter drug · ANDA
kirkland signature naproxen sodium (Naproxen sodium) NDC 63981-368
Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Costco Wholesale Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63981-368-79 | 6398103687963981036879 | 400 TABLET, FILM COATED in 1 BOTTLE (63981-368-79)Marketed from Jun 4, 2007 |
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 naproxen sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- 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 074661
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63981-368_3e9d5f27-97d9-4c43-a27c-20636ab9b13dSPL ID 3e9d5f27-97d9-4c43-a27c-20636ab9b13dSPL set ID d63cd2ad-18cf-4379-b48e-a487334ad9ccRxCUI 849574UNII 9TN87S3A3C
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N463981036879followed by a unit qualifier and the quantityPackage 63981-0368-79. 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)
Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 63981-368
- What is NDC 63981-368?
- 63981-368 is the product NDC for kirkland signature naproxen sodium, Naproxen sodium 220 mg/1 tablet, film coated, 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 naproxen sodium (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium.
- 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 naproxen sodium?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 074661
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 |
|---|---|---|---|---|
| Topcare All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-140 |
| Rugby All Day Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3009 |
| Good Sense Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0901 |
| good sense naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-1412 |
| naproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-313 |
| Berkley and Jensen Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | BJWC | 68391-368 |
| up and up naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-909 |
| Basic Care Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-331 |
| rugby all day reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3356 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 69842-811 |
| basic care naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-368 |
| equaline naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-511 |
| naproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-988 |
| Good Sense Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2584 |
| naproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | H E B | 37808-631 |
| signature care naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-180 |
| naproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | H E B | 37808-652 |
| DG Health Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-490 |
| DG Health Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-481 |
| dg health naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-500 |
Showing 20 of 39.