Over-the-counter drug · ANDA
omeprazole NDC 11822-0061
Omeprazole magnesium 20.6 mg/1 · Capsule, Delayed release · Oral · Rite Aid
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-0061-4 | 11822006104 | 3 BOTTLE in 1 CARTON (11822-0061-4) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (11822-0061-1)Marketed from Aug 5, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Rite Aid
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210593
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 11822-0061_67c3cfe2-ab40-4c32-b386-ad3c740e3f6fSPL ID 67c3cfe2-ab40-4c32-b386-ad3c740e3f6fSPL set ID b1ba65d1-8f68-4bae-bb9d-776bba348346RxCUI 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
N411822006104followed by a unit qualifier and the quantityPackage 11822-0061-04. 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 210593
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 | Capsule, Delayed releaseOral | INNOVUS PHARMACEUTICALS, INC. | 57483-740 |
| Omeprazoleomeprazole magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | UP & UP | 11673-948 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | CapsuleOral | Meijer Distribution Inc. | 79481-0061 |
| Omeprazoleomeprazole magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Walgreen Company | 0363-9980 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | CVS Pharamacy, Inc | 51316-061 |