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| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0331-1 | 8042503310180425033101 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-1)Marketed from May 2, 2023 | |
| 80425-0331-2 | 8042503310280425033102 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-2)Marketed from May 2, 2023 | |
| 80425-0331-3 | 8042503310380425033103 | 90 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
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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
N480425033101followed by a unit qualifier and the quantityPackage 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.
About NDC 80425-0331
- What is NDC 80425-0331?
- 80425-0331 is the product NDC for Esomeprazole Magnesium DR (esomeprazole magnesium), Esomeprazole magnesium 40 mg/1 capsule, delayed release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esomeprazole Magnesium DR (Esomeprazole Magnesium).
- What is the active ingredient?
- Esomeprazole magnesium.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 DR?
- 1 other product NDC are listed under this name. See all Esomeprazole Magnesium DR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esomeprazole Magnesium DR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esomeprazole Magnesium DResomeprazole magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0111 | 80425-0111-0180425-0111-02 |
Other NDCs under ANDA 211977
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6198 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-4581 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-877 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7896 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7360 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Direct Rx | 72189-318 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2018 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-905 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2040 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0419 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-904 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0420 |
| Esomeprazole DR | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Direct_Rx | 72189-381 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-664 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-665 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-934 |