Over-the-counter drug · ANDA
Naproxen (Naproxen sodium) NDC 55319-406
Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Family Dollar Services Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-406-15 | 5531904061555319040615 | 1 BOTTLE, PLASTIC in 1 CARTON (55319-406-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Dec 15, 2023 |
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)
- Naproxen
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Family Dollar Services IncNDC labeler code 55319
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204872
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55319-406_356f6f12-8219-42fa-8fd6-1f19c70b1489SPL ID 356f6f12-8219-42fa-8fd6-1f19c70b1489SPL set ID d9c63e1f-c2ad-434b-8a21-7fff21b7477bRxCUI 849574UNII 9TN87S3A3CUPC 0032251924002
- 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
N455319040615followed by a unit qualifier and the quantityPackage 55319-0406-15. 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: headache muscular aches the common cold toothache menstrual cramps backache minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 55319-406
- What is NDC 55319-406?
- 55319-406 is the product NDC for Naproxen (naproxen sodium), Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by Family Dollar Services Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Family Dollar Services Inc, NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naproxen?
- 189 other product NDCs are listed under this name. See all Naproxen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naproxen | Naproxen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-092 | 87441-0092-01 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-190 | 60760-0190-60 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4750 | 70518-4750-00 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0784 | 67046-0784-03 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Coupler LLC | 67046-0499 | 67046-0499-03 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Coupler LLC | 67046-0500 | 67046-0500-03 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0501 | 67046-0501-03 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-211 | 11534-0211-01 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-212 | 11534-0212-01 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 | 70518-4514-00 |
Other NDCs under ANDA 204872
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 |
|---|---|---|---|---|
| 24/7 Life by 7-Eleven Naproxen Sodiumnaproxen sodium tablet, film coated | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-5428 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-005 |
| AnaDentnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Belmora LLC | 27854-170 |
| Artridolnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Zapotol Products Corp | 59428-604 |
| Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-4170 |
| Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-817 |
| First Aid Direct All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Cintas Corporation | 42961-122 |
| Flanaxnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Belmora LLC | 27854-160 |
| Flanax Menstrual Pain Relievernaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Belmora LLC | 27854-165 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Better Living Brands, LLC | 21130-674 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-562 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-564 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-261 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Family Dollar Services Inc | 55319-717 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-954 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5039 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7572 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Proficient Rx LP | 71205-595 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1282 |
| Naproxen Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-714 |
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