Prescription drug · NDA
Naprelan (naproxen sodium) NDC 52427-273
Naproxen sodium 500 mg/1 · Tablet, Film coated, Extended release · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-273-75 | 52427027375 | 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-273-75)Marketed from Jan 17, 2014 |
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)
- Naprelan
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Almatica Pharma LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020353
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 52427-273_cc98185d-7e2e-eea6-8bbd-08585361b654SPL ID cc98185d-7e2e-eea6-8bbd-08585361b654SPL set ID e633ff0b-eab7-f167-8d08-e9236e54042bRxCUI 1116320, 1116331, 1116339, 1116341, 1116349, 1116351UNII 9TN87S3A3CUPC 0352427272011, 0352427274305, 0352427273759
- 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
N452427027375followed by a unit qualifier and the quantityPackage 52427-0273-75. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 020353
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 |
|---|---|---|---|---|
| Naproxen Sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Alvogen Inc. | 47781-154 |
| Naproxen Sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-252 |
| Naprelannaproxen sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-249 |
| Naprelannaproxen sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-250 |
| Naprelannaproxen sodium | Naproxen sodium 750 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-251 |
| Naproxen Sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-253 |
| Naproxen Sodium | Naproxen sodium 750 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-254 |
| Naprelannaproxen sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Almatica Pharma LLC | 52427-272 |
| Naproxen Sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | SA3, LLC | 69420-1375 |
| Naproxen Sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Alvogen Inc. | 47781-153 |