Over-the-counter drug · ANDA
omeprazole NDC 57483-840
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · INNOVUS PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-840-42 | 57483084042 | 3 BOTTLE in 1 CARTON (57483-840-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57483-840-01)Marketed from Aug 10, 2020 |
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 207891
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 57483-840_3fc301fe-e89b-488b-8437-c48b59cec420SPL ID 3fc301fe-e89b-488b-8437-c48b59cec420SPL set ID 7535a309-1a67-4f50-911b-7cf570322931RxCUI 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
N457483084042followed by a unit qualifier and the quantityPackage 57483-0840-42. 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 207891
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 | GERI-CARE PHARMACEUTICALS, CORP | 57896-659 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | VALU MERCHANDISERS COMPANY | 63941-997 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | OHM LABORATORIES INC. | 51660-029 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | BI-MART | 37835-001 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Discount Drug Mart, Inc | 53943-038 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Redpharm Drug | 67296-2183 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | STRATEGIC SOURCING SERVICES LLC | 70677-1098 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Little Pharma, Inc. | 72559-014 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | THE KROGER COMPANY | 30142-992 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Sun Pharmaceutical Industries, Inc. | 62756-377 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | HARRIS TEETER | 72036-981 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Twin Med LLC | 55681-306 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services | 70677-0148 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Living Better Brands LLC | 21130-991 |