Over-the-counter drug · ANDA
Esomeprazole Magnesium NDC 70000-0695
Esomeprazole magnesium dihydrate 20 mg/1 · Tablet, Delayed release · Oral · Cardinal Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0695-1 | 70000069501 | 1 BOTTLE in 1 CARTON (70000-0695-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jun 27, 2024 | |
| 70000-0695-2 | 70000069502 | 3 BOTTLE in 1 CARTON (70000-0695-2) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jun 27, 2024 |
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
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium dihydrate — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Cardinal Health
- 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 70000-0695_90df7bbb-c55e-4a01-90b7-c118b65617a9SPL ID 90df7bbb-c55e-4a01-90b7-c118b65617a9SPL set ID 90df7bbb-c55e-4a01-90b7-c118b65617a9RxCUI 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
N470000069501followed by a unit qualifier and the quantityPackage 70000-0695-01. 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)
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 | WALGREEN CO. | 0363-0361 |
| 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 |