Prescription drug · ANDA
Omeprazole NDC 60687-597
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-597-01 | 60687059701 | 100 BLISTER PACK in 1 CARTON (60687-597-01) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-597-11)Marketed from Dec 1, 2025 |
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
- Capsule, Delayed release
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078490
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 60687-597_459ef81b-22fe-40fe-e063-6294a90af7adSPL ID 459ef81b-22fe-40fe-e063-6294a90af7adSPL set ID 205652e1-7fbc-4b6a-bbd6-2fd346d812dfRxCUI 198051, 200329UNII 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
N460687059701followed by a unit qualifier and the quantityPackage 60687-0597-01. 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 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 2 years of age and older (1.4) Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6) Pathologic hypersecretory conditions in adults (1.7) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal wit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078490
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 40 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8771 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6721 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6720 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8805 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-747 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0504 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-608 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | AvPAK | 50268-657 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | PHOENIX RX LLC | 85509-1644 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-875 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-876 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-183 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7472 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7473 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7474 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 82868-080 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3733 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-5301 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-912 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-123 |
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