Over-the-counter drug · ANDA
Aleve-D Sinus and Cold NDC 0280-6090
naproxen sodium, pseudeoephedrine hydrochloride · Pseudoephedrine hydrochloride 120 mg/1; Naproxen sodium 220 mg/1 · Tablet · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-6090-10 | 00280609010 | 1 BLISTER PACK in 1 CARTON (0280-6090-10) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 0280-6090-20 | 00280609020 | 2 BLISTER PACK in 1 CARTON (0280-6090-20) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 1, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Aleve-D Sinus and Cold
- Generic name (nonproprietary)
- naproxen sodium, pseudeoephedrine hydrochloride
- Active ingredients
- Pseudoephedrine hydrochloride — 120 mg/1Naproxen sodium — 220 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076518
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0280-6090_4526c387-9c6e-1a47-e063-6394a90a21daSPL ID 4526c387-9c6e-1a47-e063-6394a90a21daSPL set ID 599ea6c8-03ad-536e-e053-2991aa0a83a3RxCUI 1367426UNII 6V9V2RYJ8N, 9TN87S3A3CUPC 0025866592803
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; alpha-Adrenergic Agonist
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
N400280609010followed by a unit qualifier and the quantityPackage 00280-6090-10. 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 Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076518
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 |
|---|---|---|---|---|
| Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6045 |
| Mucinex DS 12HR COLD, FEVER and SINUSnaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 72854-223 |
| All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-0650 |
| Sudafed Sinus 12 Hour Pressure plus Painnaproxen sodium and pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Kenvue Brands LLC | 50580-434 |
| Leader All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0605 |
| Sinus and Cold Dnaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-339 |
| Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution Inc | 41250-417 |
| Topcare Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-417 |