Over-the-counter drug · ANDA
Berkley and Jensen Naproxen Sodium (Naproxen sodium) NDC 68391-368
Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-368-79 | 68391036879 | 400 TABLET, FILM COATED in 1 BOTTLE (68391-368-79)Marketed from Apr 15, 2011 |
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)
- Berkley and Jensen Naproxen Sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- 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 68391-368_4c47d9e4-c0af-44df-ac59-5cac3fb7b084SPL ID 4c47d9e4-c0af-44df-ac59-5cac3fb7b084SPL set ID 9530b649-3e01-452c-99a6-cff47fa4085bRxCUI 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
N468391036879followed by a unit qualifier and the quantityPackage 68391-0368-79. 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 68391-368
- What is NDC 68391-368?
- 68391-368 is the product NDC for Berkley and Jensen Naproxen Sodium, Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Berkley and Jensen Naproxen Sodium (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Berkley and Jensen 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 |
|---|---|---|---|---|
| rugby all day reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Rugby Laboratories | 0536-1094 |
| Good Sense Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8443 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-490 |
| Basic Care Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-489 |
| TopCare All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-368 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 69842-811 |
| betr headache pain reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Live Betr LLC | 80267-001 |
| Care One Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-349 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-543 |
| CareOne Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-507 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-680 |
| Care One Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-533 |
| Topcare All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-490 |
| 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 | 55910-490 |
| dg health naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-500 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0685 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-593 |
| Good Sense Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-4368 |
| kirkland signature naproxen sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Costco Wholesale Company | 63981-368 |
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