Over-the-counter drug · ANDA
Omeprazole NDC 46122-739
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · AMERISOURCEBERGEN DRUG CORPORATION
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-739-04 | 46122073904 | 3 BOTTLE in 1 CARTON (46122-739-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 30, 2023 | |
| 46122-739-74 | 46122073974 | 1 BOTTLE in 1 CARTON (46122-739-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 30, 2023 |
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 — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207740
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 46122-739_0c214fe9-7d95-39e0-0526-2d257f47695eSPL ID 0c214fe9-7d95-39e0-0526-2d257f47695eSPL set ID 0521c51b-d113-7e35-f1a6-c4495a2bcfccRxCUI 402014UNII KG60484QX9
- 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
N446122073904followed by a unit qualifier and the quantityPackage 46122-0739-04. 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(s) 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 207740
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 20 mg/1 | Tablet, Delayed releaseOral | Walmart Inc. | 79903-305 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Walgreens Company | 0363-1607 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Chain Drug Marketing Association INC | 83324-141 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dr. Reddys Laboratories Inc | 43598-286 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-441 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dr. Reddys Laboratories Inc | 43598-841 |