Over-the-counter drug · ANDA
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold NDC 58602-816
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 |
|---|---|---|---|
| 58602-816-67 | 5860208166758602081667 | 2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2022 | |
| 58602-816-72 | 5860208167258602081672 | 3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 12, 2025 | |
| 58602-816-83 | 5860208168358602081683 | 1 BLISTER PACK in 1 CARTON (58602-816-83) / 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 Cold
- 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 LLCNDC labeler code 58602
- 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 58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531SPL ID 554a4cb1-aaac-44f9-99c7-f342abdc3531SPL set ID 638a9664-4129-46fd-9ba1-d660a7366c9fRxCUI 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
N458602081667followed by a unit qualifier and the quantityPackage 58602-0816-67. 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.
About NDC 58602-816
- What is NDC 58602-816?
- 58602-816 is the product NDC for Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold, Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Aurohealth LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold (Naproxen Sodium and Pseudoephedrine Hydrochloride).
- What is the active ingredient?
- Naproxen sodium, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold?
- 1 other product NDC are listed under this name. See all Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headachenaproxen sodium and pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-832 | 58602-0832-6758602-0832-83 |
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 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 |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headachenaproxen sodium and pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-832 |