Prescription drug · ANDA
Omeprazole NDC 85534-0064
Omeprazole 10 mg/1 · Capsule, Delayed release · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0064-0 | 85534006400 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0064-0)Marketed from Jul 13, 2026 | |
| 85534-0064-1 | 85534006401 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0064-1)Marketed from Jul 13, 2026 | |
| 85534-0064-2 | 85534006402 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0064-2)Marketed from Jul 13, 2026 | |
| 85534-0064-3 | 85534006403 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0064-3)Marketed from Jul 13, 2026 |
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 — 10 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091672
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 85534-0064_567a8302-5812-1266-e063-6294a90a2157SPL ID 567a8302-5812-1266-e063-6294a90a2157SPL set ID 9359e826-5263-44fc-8dd3-9d0852fe42d6RxCUI 198051, 199119, 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
N485534006400followed by a unit qualifier and the quantityPackage 85534-0064-00. 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 are 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 u…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091672
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 | Preferred Pharmaceuticals Inc. | 68788-6881 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3007 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-6995 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NuCarePharmaceuticals, Inc. | 68071-2199 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8079 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-2251 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-063 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5501 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | PHOENIX RX LLC | 85509-1396 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-841 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-820 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-055 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-828 |
| Omeprazole DRomeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0070 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1639 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-501 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4024 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-280 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-3876 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-942 |
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