NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2552Add 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
71335-2552-1713352552017133525520160 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2552-1)Marketed from Jan 21, 2025
71335-2552-2713352552027133525520230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2552-2)Marketed from Jan 21, 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 PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217738
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 71335-2552_c89ae20b-9b58-43d9-9f9f-49268d04e70aSPL ID c89ae20b-9b58-43d9-9f9f-49268d04e70aSPL set ID f3a3eea2-f6b3-4559-8536-26c1125df3e1RxCUI 994008UNII 57Y76R9ATQ, R6DXU4WAY9

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

N471335255201 followed by a unit qualifier and the quantity

Package 71335-2552-01. 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 . 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 tablets are 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 esomepraz…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2552

What is NDC 71335-2552?
71335-2552 is the product NDC for Naproxen and esomeprazole magnesium, Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 tablet, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen and esomeprazole magnesium.
What is the active ingredient?
Naproxen, Esomeprazole magnesium.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. 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 and esomeprazole magnesium?
20 other product NDCs are listed under this name. See all Naproxen and esomeprazole magnesium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naproxen and esomeprazole magnesium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Naproxen and esomeprazole magnesiumNaproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-416668788-4166-0368788-4166-06
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-404368788-4043-0368788-4043-06
Naproxen and esomeprazole magnesiumNaproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc68788-890668788-8906-0368788-8906-06
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-876668788-8766-0368788-8766-06
Naproxen and esomeprazole magnesiumNaproxen 375 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralScieGen Pharmaceuticals, Inc50228-43750228-0437-1050228-0437-3050228-0437-60
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralScieGen Pharmaceuticals, Inc50228-43850228-0438-0550228-0438-3050228-0438-60
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralProficient Rx LP82804-30382804-0303-60
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralPHOENIX RX LLC85509-143885509-1438-0185509-1438-0385509-1438-06+1 more
Naproxen and esomeprazole magnesiumNaproxen 375 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralAjanta Pharma USA Inc.27241-20227241-0202-60
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralAjanta Pharma USA Inc.27241-20327241-0203-60

All 21 Naproxen and esomeprazole magnesium NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Naproxen and esomeprazole magnesiumNaproxen 375 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralScieGen Pharmaceuticals, Inc50228-437
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralScieGen Pharmaceuticals, Inc50228-438
Naproxen and esomeprazole magnesiumNaproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc68788-8906
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1Tablet, Delayed releaseOralProficient Rx LP82804-303
Naproxen and esomeprazole magnesiumNaproxen 500 mg/1; Esomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralPHOENIX RX LLC85509-1438

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