NDC codes

FDA NDC Directory
Product NDC (as listed)71179-816Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71179-0816Add 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 NDC11-digit (billing)PackageCopy
71179-816-24711790816243 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 7, 2024

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 Cold And Sinus
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
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 71179-816_10b76575-5016-447e-b651-f33546f4e53bSPL ID 10b76575-5016-447e-b651-f33546f4e53bSPL set ID a973cb82-1e00-4706-8b96-648135ea48a1RxCUI 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

N471179081624 followed by a unit qualifier and the quantity

Package 71179-0816-24. 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.

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
ProductStrengthForm · routeLabelerProduct NDC
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Coldnaproxen sodium and pseudoephedrine hydrochlorideNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralAurohealth LLC58602-816
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headachenaproxen sodium and pseudoephedrine hydrochlorideNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralAurohealth LLC58602-832

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