Over-the-counter drug · ANDA
Omeprazole Magnesium NDC 57896-759
Omeprazole magnesium 20.6 mg/1 · Capsule, Delayed release · Oral · Gericare Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57896-759-14 | 57896075914 | 1 BOTTLE in 1 CARTON (57896-759-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 1, 2016 | |
| 57896-759-28 | 57896075928 | 2 BOTTLE in 1 CARTON (57896-759-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 1, 2016 | |
| 57896-759-42 | 57896075942 | 3 BOTTLE in 1 CARTON (57896-759-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 1, 2016 |
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 Magnesium
- Generic name (nonproprietary)
- omeprazole magnesium
- Active ingredients
- Omeprazole magnesium — 20.6 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Gericare Pharmaceuticals
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078878
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 57896-759_3b0207de-ac3b-e214-e063-6294a90a59fcSPL ID 3b0207de-ac3b-e214-e063-6294a90a59fcSPL set ID 0e1f5d7c-5956-3be7-e054-00144ff8d46cRxCUI 198051UNII 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
N457896075914followed by a unit qualifier and the quantityPackage 57896-0759-14. 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)
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 078878
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 Magnesiumomeprazole magnesium 20.6mg capsules | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | The Kroger Co. | 30142-012 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association | 63868-177 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Consortium, LLC | 68016-760 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | HEB | 37808-006 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-397 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Walgreens Company | 0363-0042 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | CVS Health Corp. | 69842-027 |
| Acid Reduceromeprazole magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0232 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association | 83324-117 |
| Omeprazole Magnesiumomeprazole magnesium 20.6mg capsules | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Wal-Mart Stores Inc | 49035-397 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc. | 43598-813 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Discount Drug Mart, Inc | 53943-520 |
| Omeprazole Magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Albertsons Companies | 21130-398 |