What is NDC 76420-889?

76420-889 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 Asclemed USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Naproxen, Esomeprazole magnesium.

Asclemed USA, Inc., NDC labeler code 76420. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naproxen and esomeprazole magnesium NDC 76420-889

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-889Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0889Add 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
76420-889-01	7642008890176420088901	100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01)Marketed from Dec 28, 2024
76420-889-30	7642008893076420088930	30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30)Marketed from Dec 28, 2024
76420-889-60	7642008896076420088960	60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60)Marketed from Dec 28, 2024
76420-889-90	7642008899076420088990	90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90)Marketed from Dec 28, 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 — 500 mg/1Esomeprazole magnesium — 20 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204206
Marketing start: Feb 18, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 76420-889_2a4fb535-ba1a-05d6-e063-6394a90a0b29SPL ID 2a4fb535-ba1a-05d6-e063-6394a90a0b29SPL set ID 7b3af5a8-0c92-43f4-af13-7a47dca20e92RxCUI 994005, 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

N476420088901 followed by a unit qualifier and the quantity

Package 76420-0889-01. 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 Dec 28, 2024. 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)

About NDC 76420-889

What is NDC 76420-889?: 76420-889 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 Asclemed USA, Inc.. It has 4 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?: Asclemed USA, Inc., NDC labeler code 76420. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-4166	68788-4166-0368788-4166-06
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-4043	68788-4043-0368788-4043-06
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc	68788-8906	68788-8906-0368788-8906-06
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8766	68788-8766-0368788-8766-06
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	ScieGen Pharmaceuticals, Inc	50228-437	50228-0437-1050228-0437-3050228-0437-60
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	ScieGen Pharmaceuticals, Inc	50228-438	50228-0438-0550228-0438-3050228-0438-60
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-2552	71335-2552-0171335-2552-02
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	82804-303	82804-0303-60
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	PHOENIX RX LLC	85509-1438	85509-1438-0185509-1438-0385509-1438-06+1 more
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Ajanta Pharma USA Inc.	27241-202	27241-0202-60

All 21 Naproxen and esomeprazole magnesium NDCs

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 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	Dr. Reddy's Laboratories Limited	55111-701
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 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Doc Rx	69306-005
Naproxen and esomeprazole magnesium	Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-2553
Naproxen and esomeprazole magnesium	Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-890