What is NDC 76420-227?

76420-227 is the product NDC for Esomeprazole magnesium, Esomeprazole magnesium 40 mg/1 capsule, coated pellets, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Esomeprazole magnesium (Esomeprazole magnesium delayed release capsules).

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 Esomeprazole magnesium?

179 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Esomeprazole magnesium NDC 76420-227

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-227Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0227Add 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
76420-227-30	7642002273076420022730	30 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30)Marketed from Jul 27, 2022
76420-227-60	7642002276076420022760	60 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60)Marketed from Jul 27, 2022
76420-227-90	7642002279076420022790	90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90)Marketed from Jul 27, 2022

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): Esomeprazole magnesium
Generic name (nonproprietary): esomeprazole magnesium delayed release capsules
Active ingredients: Esomeprazole magnesium — 40 mg/1
Dosage form: Capsule, Coated pellets
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210559
Marketing start: Feb 27, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565SPL ID 23b36bd4-0dbd-366a-e063-6294a90a1565SPL set ID 85a963c1-9c13-4eb7-826b-08d5a991fe28RxCUI 606726, 606730UNII R6DXU4WAY9
Pharmacologic class: 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

N476420022730 followed by a unit qualifier and the quantity

Package 76420-0227-30. 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 Oct 4, 2024.

Indications (excerpt from the label)

Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD) ( 1.1 ) Risk reduction of NSAID-associated gastric ulcer ( 1.2 ) H. pylori eradication to reduce the risk of duodenal ulcer recurrence ( 1.3 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome ( 1.4 ) 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-227

What is NDC 76420-227?: 76420-227 is the product NDC for Esomeprazole magnesium, Esomeprazole magnesium 40 mg/1 capsule, coated pellets, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Esomeprazole magnesium (Esomeprazole magnesium delayed release capsules).
What is the active ingredient?: 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 Esomeprazole magnesium?: 179 other product NDCs are listed under this name. See all 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 Esomeprazole magnesium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-4776	70518-4776-00
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Chain Drug Marketing Association, Inc.	83324-328	83324-0328-1483324-0328-42
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	St. Mary's Medical Park Pharmacy	60760-877	60760-0877-60
Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-563	72288-0563-01
esomeprazole magnesiumesomeprazole magnesium dihydrate	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-780	72288-0780-03
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	American Health Packaging	60687-934	60687-0934-21
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-669	72288-0669-0172288-0669-03
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	H-E-B	37808-646	37808-0646-4137808-0646-4537808-0646-82
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Rising Pharma Holdings, Inc.	64980-664	64980-0664-1964980-0664-41
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	CapsuleOral	YYBA CORP	73581-014	73581-0014-42

All 180 Esomeprazole magnesium NDCs

Other NDCs under ANDA 210559

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

FDA NDC Directory listings under ANDA 210559
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole magnesiumesomeprazole magnesium delayed release capsules	Esomeprazole magnesium 20 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-571
Esomeprazole magnesiumesomeprazole magnesium delayed release capsules	Esomeprazole magnesium 40 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-572
Esomeprazole magnesiumesomeprazole magnesium delayed release capsules	Esomeprazole magnesium trihydrate 20 mg/1	Capsule, Coated pelletsOral	Proficient Rx LP	71205-706
Esomeprazole magnesiumesomeprazole magnesium delayed release capsules	Esomeprazole magnesium 20 mg/1	Capsule, Coated pelletsOral	Bryant Ranch Prepack	71335-9678
Esomeprazole magnesiumesomeprazole magnesium delayed release capsules	Esomeprazole magnesium 20 mg/1	Capsule, Coated pelletsOral	Asclemed USA, Inc.	76420-226