Naproxen and esomeprazole magnesium NDC 50228-437

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-437Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0437Add 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
50228-437-10	50228043710	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-10)Marketed from Oct 11, 2023
50228-437-30	50228043730	30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-30)Marketed from Oct 11, 2023
50228-437-60	50228043760	60 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-60)Marketed from Mar 12, 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 and esomeprazole magnesium
Generic name (nonproprietary): naproxen and esomeprazole magnesium
Active ingredients: Naproxen — 375 mg/1Esomeprazole magnesium — 20 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: ScieGen Pharmaceuticals, Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217738
Marketing start: Oct 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 50228-437_2faf3061-f567-a5dc-e063-6294a90aff8bSPL ID 2faf3061-f567-a5dc-e063-6294a90aff8bSPL set ID 167340c2-1234-4d00-b4e2-cccf3d270fdaRxCUI 994005, 994008UNII R6DXU4WAY9, 57Y76R9ATQUPC 0350228437103, 0350228438605, 0350228438056, 0350228437301, 0350228437608, 0350228438308
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; Proton Pump Inhibitor

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

N450228043710 followed by a unit qualifier and the quantity

Package 50228-0437-10. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 217738

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

FDA NDC Directory listings under ANDA 217738
Product	Strength	Form · route	Labeler	Product NDC
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	PHOENIX RX LLC	85509-1438
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc	68788-8906
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	ScieGen Pharmaceuticals, Inc	50228-438
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-2552
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	82804-303