Prescription drug · NDA AUTHORIZED GENERIC
Naproxen Sodium NDC 24979-252
Naproxen sodium 375 mg/1 · Tablet, Film coated, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24979-252-01 | 24979025201 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-252-01)Marketed from Apr 25, 2024 |
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 Sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 375 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020353
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 24979-252_a79a3bf0-fe2f-4ba4-8eaa-e1c97ab9b927SPL ID a79a3bf0-fe2f-4ba4-8eaa-e1c97ab9b927SPL set ID 7c22a2d6-821c-4f83-aead-e756aed930e5RxCUI 1116320, 1116339, 1116349UNII 9TN87S3A3CUPC 0324979252018, 0324979254067, 0324979253688
- 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
N424979025201followed by a unit qualifier and the quantityPackage 24979-0252-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [ see Warnings and Precautions ( 5 ) ]. Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)( 1 ) osteoarthritis (OA)( 1 ) ankylosing spondylitis (AS)( 1 ) tendinitis, bursitis ( 1 ) acute gout ( 1 ) primary dysmenorrhea (PD)( 1 ) the relief of mild to moderate pain ( 1 )
Excerpt only. Read the full label for complete information.
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 |
| 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 |
| Naprelannaproxen sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Almatica Pharma LLC | 52427-273 |
| 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 |