Over-the-counter drug · ANDA
Esomeprazole Magnesium NDC 0363-0361
Esomeprazole magnesium dihydrate 20 mg/1 · Tablet, Delayed release · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0361-42 | 00363036142 | 3 BOTTLE in 1 CARTON (0363-0361-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 8, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- WALGREEN CO.
- 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 0363-0361_c6e874bf-fe37-4820-ab9c-224e8daa1194SPL ID c6e874bf-fe37-4820-ab9c-224e8daa1194SPL set ID 179b23c4-2a6c-f658-e063-6394a90a82b3RxCUI 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
N400363036142followed by a unit qualifier and the quantityPackage 00363-0361-42. 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 | Aurohealth LLC | 58602-840 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Tablet, Delayed releaseOral | CVS Pharmacy, Inc. | 51316-088 |