Over-the-counter drug · ANDA
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache NDC 58602-832
naproxen sodium and pseudoephedrine hydrochloride · Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-832-67 | 58602083267 | 2 BLISTER PACK in 1 CARTON (58602-832-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2022 | |
| 58602-832-83 | 58602083283 | 1 BLISTER PACK in 1 CARTON (58602-832-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2022 |
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 and Pseudoephedrine Hydrochloride Sinus and Headache
- Generic name (nonproprietary)
- naproxen sodium and pseudoephedrine hydrochloride
- Active ingredients
- Naproxen sodium — 220 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211360
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-832_0287563f-3472-401d-b95f-9694258def17SPL ID 0287563f-3472-401d-b95f-9694258def17SPL set ID 10a8a74b-11d1-490e-87e7-d705fe0e7602RxCUI 1367426UNII 9TN87S3A3C, 6V9V2RYJ8N
- 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
N458602083267followed by a unit qualifier and the quantityPackage 58602-0832-67. 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 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 211360
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 and Pseudoephedrine Hydrochloride Sinus and Coldnaproxen sodium and pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-816 |
| Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinusnaproxen sodium and pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-816 |