NDC 58602-816

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-816Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0816Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
58602-816-67	58602081667	2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2022
58602-816-72	58602081672	3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 12, 2025
58602-816-83	58602081683	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 LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211360
Marketing start: Jun 1, 2022
Listing expires: Dec 31, 2026
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

N458602081667 followed by a unit qualifier and the quantity

Package 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 Feb 12, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211360

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211360
Product	Strength	Form · route	Labeler	Product NDC
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
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 Cold NDC 58602-816