Over-the-counter drug · ANDA
Omeprazole 20 mg NDC 25000-091
Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-091-76 | 25000009176 | 1 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 12, 2025 | |
| 25000-091-77 | 25000009177 | 2 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 12, 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)
- Omeprazole 20 mg
- Generic name (nonproprietary)
- omeprazole 20 mg
- Active ingredients
- Omeprazole magnesium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITED
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218829
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cecSPL ID dcf79426-6aec-432a-aabe-dcb98c0f2cecSPL set ID 921bf750-9dd7-42ff-82bb-043b03f0fe69RxCUI 402014UNII 426QFE7XLKUPC 0325000091767, 0325000091774
- 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
N425000009176followed by a unit qualifier and the quantityPackage 25000-0091-76. 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)
USE(S) 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 218829
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 |
|---|---|---|---|---|
| Omeprazole delayed releaseomeprazole 20mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | TIME CAP LABORATORIES, INC. | 49483-731 |
| Omeprazole 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-094 |
| Omeprazole Delayed-Releaseomeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | H-E-B | 37808-569 |
| 24 HOUR Omeprazoleomeprazole 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Grocery Outlet, Inc. | 85828-731 |
- 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.