Prescription drug · ANDA
Omeprazole NDC 71205-157
Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-157-30 | 71205015730 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-157-30)Marketed from Nov 1, 2018 | |
| 71205-157-60 | 71205015760 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-157-60)Marketed from Nov 1, 2018 | |
| 71205-157-90 | 71205015790 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-157-90)Marketed from Nov 1, 2018 |
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 — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075410
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-157_9ee846e2-6191-4e7c-bdbe-86f868eecad6SPL ID 9ee846e2-6191-4e7c-bdbe-86f868eecad6SPL set ID 9786b04f-f827-460b-91bc-c0ac967f95ddRxCUI 200329UNII KG60484QX9UPC 0371205157609
- 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
N471205015730followed by a unit qualifier and the quantityPackage 71205-0157-30. 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)
Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults (1.1) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) Treatment of active benign gastric ulcer in adults (1.3) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) Pathologic hypersecretory conditions in adults (1.7) 1.1 Treatment of Active Duodenal Ulcer Omep…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075410
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 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2243 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1532 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-829 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-155 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Chartwell RX, LLC | 62135-530 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4906 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4025 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Lannett Company, Inc. | 62175-114 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Lannett Company, Inc. | 62175-118 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Lannett Company, Inc. | 62175-136 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1746 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.