Over-the-counter drug · ANDA
Esomeprazole Magnesium NDC 58602-840
Esomeprazole magnesium dihydrate 20 mg/1 · Tablet, Delayed release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-840-05 | 58602084005 | 1 BOTTLE in 1 CARTON (58602-840-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 12, 2023 | |
| 58602-840-61 | 58602084061 | 2 BOTTLE in 1 CARTON (58602-840-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 12, 2023 | |
| 58602-840-62 | 58602084062 | 3 BOTTLE in 1 CARTON (58602-840-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 12, 2023 |
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
- Active ingredients
- Esomeprazole magnesium dihydrate — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214473
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-840_5ddd44f1-1baa-4730-b718-5d1c326ecd49SPL ID 5ddd44f1-1baa-4730-b718-5d1c326ecd49SPL set ID 034bcbad-f57f-4338-a193-7a5aa9f09aa6RxCUI 433733UNII 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
N458602084005followed by a unit qualifier and the quantityPackage 58602-0840-05. 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)
Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214473
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 dihydrate 20 mg/1 | Tablet, Delayed releaseOral | Cardinal Health | 70000-0695 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Tablet, Delayed releaseOral | WALGREEN CO. | 0363-0361 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Tablet, Delayed releaseOral | CVS Pharmacy, Inc. | 51316-088 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.