Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Naproxen Sodium; Pseudoephedrine Hydrochloride.
| Product ID | 58602-816_638a9664-4129-46fd-9ba1-d660a7366c9f |
| NDC | 58602-816 |
| Product Type | Human Otc Drug |
| Proprietary Name | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold |
| Generic Name | Naproxen Sodium And Pseudoephedrine Hydrochloride |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-06-01 |
| Marketing Category | ANDA / |
| Application Number | ANDA211360 |
| Labeler Name | Aurohealth LLC |
| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Active Ingredient Strength | 220 mg/1; mg/1 |
| Pharm Classes | Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 58602-816 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | Naproxen Sodium and Pseudoephedrine Hydrochloride |
| 58602-832 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | Naproxen Sodium and Pseudoephedrine Hydrochloride |
| 50580-539 | Sudafed | Naproxen sodium and Pseudoephedrine Hydrochloride |
| 50580-434 | Sudafed Sinus 12 Hour Pressure plus Pain | Naproxen sodium and Pseudoephedrine Hydrochloride |