Over-the-counter drug · ANDA
24 HOUR Omeprazole (Omeprazole 20 mg) NDC 85828-731
Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · Grocery Outlet, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85828-731-45 | 8582807314585828073145 | 1 BOTTLE in 1 CARTON (85828-731-45) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 25, 2026 |
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)
- 24 HOUR Omeprazole
- Generic name (nonproprietary)
- omeprazole 20 mg
- Active ingredients
- Omeprazole magnesium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Grocery Outlet, Inc.NDC labeler code 85828
- 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 85828-731_4db11e95-b324-1be9-e063-6294a90a5586SPL ID 4db11e95-b324-1be9-e063-6294a90a5586SPL set ID 4466f17c-c27b-8393-e063-6394a90a803dRxCUI 402014UNII 426QFE7XLK
- 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
N485828073145followed by a unit qualifier and the quantityPackage 85828-0731-45. 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.
About NDC 85828-731
- What is NDC 85828-731?
- 85828-731 is the product NDC for 24 HOUR Omeprazole (omeprazole 20 mg), Omeprazole magnesium 20 mg/1 tablet, delayed release, listed with the FDA by Grocery Outlet, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 24 HOUR Omeprazole (Omeprazole 20 mg).
- What is the active ingredient?
- Omeprazole magnesium.
- Who is the labeler?
- Grocery Outlet, Inc., NDC labeler code 85828. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 24 HOUR Omeprazole?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-091 |
| Omeprazole 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-094 |
| Omeprazole delayed releaseomeprazole 20mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | TIME CAP LABORATORIES, INC. | 49483-731 |
| Omeprazole Delayed-Releaseomeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | H-E-B | 37808-569 |