Prescription drug · NDA
Naprelan (Naproxen sodium) NDC 52427-272
Naproxen sodium 375 mg/1 · Tablet, Film coated, Extended release · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-272-01 | 5242702720152427027201 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-272-01)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 — 375 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Almatica Pharma LLCNDC labeler code 52427
- 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 52427-272_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
N452427027201followed by a unit qualifier and the quantityPackage 52427-0272-01. 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)
NAPRELAN 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 )] . NAPRELAN 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.
About NDC 52427-272
- What is NDC 52427-272?
- 52427-272 is the product NDC for Naprelan (naproxen sodium), Naproxen sodium 375 mg/1 tablet, film coated, extended release, listed with the FDA by Almatica Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naprelan (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Almatica Pharma LLC, NDC labeler code 52427. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naprelan?
- 4 other product NDCs are listed under this name. See all Naprelan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naprelan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naprelannaproxen sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-249 | 24979-0249-01 |
| Naprelannaproxen sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-250 | 24979-0250-68 |
| Naprelannaproxen sodium | Naproxen sodium 750 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-251 | 24979-0251-06 |
| Naprelannaproxen sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Almatica Pharma LLC | 52427-273 | 52427-0273-75 |
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 |
|---|---|---|---|---|
| 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 |
| 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 | Upsher-Smith Laboratories, LLC | 24979-252 |
| Naproxen Sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-253 |
| Naproxen Sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Alvogen Inc. | 47781-153 |
| 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 | SA3, LLC | 69420-1375 |