Data / Drug companies / Naproxen sodium and pseudoephedrine hydrochloride
Naproxen sodium and pseudoephedrine hydrochloride: 3 companies and 4 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Naproxen sodium and pseudoephedrine hydrochloride is listed in the FDA National Drug Code Directory by 3 companies, with 4 products in commercial distribution. 4 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, extended release; tablet, multilayer, extended release, and the newest product started marketing on August 7, 2024.
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- Companies listing it
- 3
- Products
- 4
- Generic (ANDA) products
- 4 (100.0%)
- Application numbers
- 2
- Routes
- Oral
- Brand names
- Sudafed Sinus 12 Hour Pressure Plus Pain
- openFDA record search
- api.fda.gov
Companies that list naproxen sodium and pseudoephedrine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Aurohealth LLC | 2 | tablet, extended release | Generic drugs (ANDA) | June 1, 2022 |
| Kenvue Brands LLC | 1 | tablet, multilayer, extended release | Generic drugs (ANDA) | June 17, 2019 |
| Vespyr Brands LLC | 1 | tablet, extended release | Generic drugs (ANDA) | August 7, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, extended release | 3 | 75% |
| Tablet, multilayer, extended release | 1 | 25% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 4 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nonsteroidal Anti-inflammatory Drug | 4 |
| alpha-Adrenergic Agonist | 4 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.