Naproxen and esomeprazole magnesium NDC 71335-2553

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2553Add 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	Copy
71335-2553-1	71335255301	60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2553-1)Marketed from Jan 23, 2025
71335-2553-2	71335255302	30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2553-2)Marketed from Jan 23, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 500 mg/1Esomeprazole magnesium — 20 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204206
Marketing start: Feb 18, 2020
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 71335-2553_42df5e08-0674-4cc5-9416-f98baea01ed8SPL ID 42df5e08-0674-4cc5-9416-f98baea01ed8SPL set ID 3f1c66f0-2d9d-4be1-8656-1dbed2c9c715RxCUI 994008UNII 57Y76R9ATQ, R6DXU4WAY9
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

N471335255301 followed by a unit qualifier and the quantity

Package 71335-2553-01. 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 Jan 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. • juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomepr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204206

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

FDA NDC Directory listings under ANDA 204206
Product	Strength	Form · route	Labeler	Product NDC
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-4043
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Dr. Reddy's Laboratories Limited	55111-289
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-889
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-890
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Dr. Reddy's Laboratories Limited	55111-701
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Doc Rx	69306-005