Over-the-counter drug · ANDA
Rapidol Naproxen (Naproxen sodium) NDC 55758-048
Naproxen sodium 220 mg/1 · Tablet, Coated · Oral · Pharmadel LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55758-048-02 | 5575800480255758004802 | 2 TABLET, COATED in 1 PACKET (55758-048-02)Marketed from Oct 24, 2023 | |
| 55758-048-24 | 5575800482455758004824 | 1 BOTTLE in 1 CARTON (55758-048-24) / 24 TABLET, COATED in 1 BOTTLEMarketed from Oct 9, 2019 | |
| 55758-048-50 | 5575800485055758004850 | 25 PACKET in 1 CARTON (55758-048-50) / 2 TABLET, COATED in 1 PACKET (55758-048-02)Marketed from Oct 24, 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)
- Rapidol Naproxen
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Pharmadel LLCNDC labeler code 55758
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091353
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55758-048_4d7ad592-5b3b-e731-e063-6394a90a11e0SPL ID 4d7ad592-5b3b-e731-e063-6394a90a11e0SPL set ID c94c4b6e-a48b-cee5-e053-2995a90a49acRxCUI 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
N455758004802followed by a unit qualifier and the quantityPackage 55758-0048-02. 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 from arthritis menstrual cramps muscular aches headache backache toothache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 55758-048
- What is NDC 55758-048?
- 55758-048 is the product NDC for Rapidol Naproxen (naproxen sodium), Naproxen sodium 220 mg/1 tablet, coated, listed with the FDA by Pharmadel LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rapidol Naproxen (Naproxen sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rapidol Naproxen?
- 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 091353
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 |
|---|---|---|---|---|
| All Day Pain Reliefnaproxen sodium tablets, 220 mg | Naproxen sodium 220 mg/1 | TabletOral | HealthLife of USA LLC | 69517-109 |
| Dr Simi All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-104 |
| Naproxen | Naproxen sodium 220 mg/1 | TabletOral | Safeway, Inc | 21130-062 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | TARGET CORPORATION | 11673-764 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | Safeway, Inc | 21130-061 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | CVS | 51316-761 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | CVS | 51316-762 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | Granules India Ltd | 62207-327 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | Granules India Ltd | 62207-328 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | Granules India Ltd | 62207-728 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | Granules India Ltd | 62207-729 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Granules India Ltd | 62207-761 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Granules India Ltd | 62207-762 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coated, Extended releaseOral | SPIRIT PHARMACEUTICALS,LLC | 68210-4096 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | Granules USA, Inc. | 69848-010 |
| Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Gobrands, Inc | 82501-1576 |
| Proxen Np 660naproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | OPMX LLC | 69729-123 |