Prescription drug · ANDA
Esomeprazole magnesium NDC 69097-507
Esomeprazole magnesium dihydrate 2.5 mg/1 · For suspension · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-507-31 | 69097050731 | 30 FOR SUSPENSION in 1 CARTON (69097-507-31)Marketed from Jan 7, 2025 |
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 — 2.5 mg/1
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217714
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-507_75c5150c-7eab-4f85-9c34-80c0ecb4a07bSPL ID 75c5150c-7eab-4f85-9c34-80c0ecb4a07bSPL set ID e89589f1-945e-429a-819e-61755cba77faRxCUI 1297658, 1297761UNII 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
N469097050731followed by a unit qualifier and the quantityPackage 69097-0507-31. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 217714
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 5 mg/1 | For suspensionOral | Cipla USA Inc. | 69097-508 |