Over-the-counter drug · ANDA
Omeprazole NDC 59726-298
Omeprazole magnesium 20.6 mg/1 · Tablet, Delayed release · Oral · P & L Development, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59726-298-14 | 59726029814 | 1 BOTTLE, PLASTIC in 1 BOX (59726-298-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTICMarketed from Jan 31, 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
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole magnesium — 20.6 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- P & L Development, LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206582
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 59726-298_1ef5cd55-c1c3-40a9-9486-91ad26c24a1cSPL ID 1ef5cd55-c1c3-40a9-9486-91ad26c24a1cSPL set ID 44a92926-1941-4fe8-9b2a-31a45289456fRxCUI 402014UNII 426QFE7XLKUPC 0359726051149
- 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
N459726029814followed by a unit qualifier and the quantityPackage 59726-0298-14. 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 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 206582
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 | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | Walgreens | 0363-9510 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | WALMART INC. (see also Equate) | 79903-377 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-219 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | WinCo Foods, LLC | 67091-464 |
| Omeprazole Delayed releaseomeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | H2-Pharma, LLC | 61269-720 |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-300 |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-301 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | P & L Development, LLC | 59726-740 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | P & L Development, LLC | 59726-744 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-4080 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-2970 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-7370 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-8040 |