Prescription drug · ANDA

Esomeprazole Magnesium DR (esomeprazole magnesium) NDC 80425-0331

Esomeprazole magnesium 40 mg/1 · Capsule, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0331Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0331Add 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
80425-0331-18042503310130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-1)Marketed from May 2, 2023
80425-0331-28042503310260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-2)Marketed from May 2, 2023
80425-0331-38042503310390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-3)Marketed from May 2, 2023

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)
Esomeprazole Magnesium DRSuffix: DR
Generic name (nonproprietary)
esomeprazole magnesium
Active ingredients
Esomeprazole magnesium — 40 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211977
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 80425-0331_2a9b9724-0260-e829-e063-6394a90a1c07SPL ID 2a9b9724-0260-e829-e063-6394a90a1c07SPL set ID fab87a2d-79c8-6045-e053-6394a90a2368RxCUI 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

N480425033101 followed by a unit qualifier and the quantity

Package 80425-0331-01. 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 .

Indications (excerpt from the label)

1. Indications and Usage 1.1 Healing of Erosive Esophagitis (EE) Adults Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 1.2 Maintenance of Healing of EE Es…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211977

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

FDA NDC Directory listings under ANDA 211977
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7896
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7360
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-934
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-4581
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-877
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralCamber Pharmaceuticals, Inc.31722-665
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCamber Pharmaceuticals, Inc.31722-664
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6198
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralDirect Rx72189-318
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-2018
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-2040
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0419
Esomeprazole DREsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDirect_Rx72189-381
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-905
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0420
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-904

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