Prescription drug · ANDA
Esomeprazole Magnesium DR (Esomeprazole magnesium) NDC 80425-0111
Esomeprazole magnesium dihydrate 20 mg/1 · Capsule, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0111-1 | 8042501110180425011101 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-1)Marketed from Apr 21, 2016 | |
| 80425-0111-2 | 8042501110280425011102 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-2)Marketed from Apr 21, 2016 |
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 dihydrate — 20 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 205606
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0111_2a99b1dd-becb-79f9-e063-6394a90a35f3SPL ID 2a99b1dd-becb-79f9-e063-6394a90a35f3SPL set ID b4cd8ed1-d9d1-5b57-e053-2995a90a9f3cRxCUI 606726UNII 36H71644EQ
- 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
N480425011101followed by a unit qualifier and the quantityPackage 80425-0111-01. 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 Section 1 INDICATIONS AND USAGE 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis 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 erosive esophagitis. 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. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlle…
Excerpt only. Read the full label for complete information.
About NDC 80425-0111
- What is NDC 80425-0111?
- 80425-0111 is the product NDC for Esomeprazole Magnesium DR (esomeprazole magnesium), Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 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 dihydrate.
- 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 40 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0331 | 80425-0331-0180425-0331-0280425-0331-03 |
Other NDCs under ANDA 205606
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 trihydrate 40 mg/1 | Capsule, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8628 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7990 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7991 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 40 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 65862-784 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0807 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-352 |