Prescription drug · ANDA
Omeprazole NDC 70518-4177
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4177-0 | 70518417700 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-4177-0)Marketed from Sep 18, 2024 | |
| 70518-4177-1 | 70518417701 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-1)Marketed from Feb 21, 2025 | |
| 70518-4177-2 | 70518417702 | 45 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-2)Marketed from Apr 30, 2025 | |
| 70518-4177-3 | 70518417703 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-3)Marketed from Jun 13, 2025 | |
| 70518-4177-4 | 70518417704 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-4)Marketed from Aug 20, 2025 | |
| 70518-4177-5 | 70518417705 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-5)Marketed from Feb 18, 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 — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- 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 70518-4177_5a1de2b5-8ef3-f37b-e063-6394a90ae77eSPL ID 5a1de2b5-8ef3-f37b-e063-6394a90ae77eSPL set ID 63b3982a-b541-4b0d-99d4-93a673e57d46RxCUI 198051UNII 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
N470518417700followed by a unit qualifier and the quantityPackage 70518-4177-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | American Health Packaging | 60687-597 |
| 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 |
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