Prescription drug · ANDA
Omeprazole NDC 51655-893
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-893-25 | 51655089325 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-25)Marketed from Sep 19, 2022 | |
| 51655-893-26 | 51655089326 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-26)Marketed from Aug 23, 2022 | |
| 51655-893-83 | 51655089383 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-83)Marketed from Feb 15, 2024 | |
| 51655-893-84 | 51655089384 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-84)Marketed from Sep 19, 2022 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075757
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 51655-893_4974171a-c249-7eab-e063-6294a90a6e80SPL ID 4974171a-c249-7eab-e063-6294a90a6e80SPL set ID f76c23d5-26b6-cfb2-e053-6294a90aea42RxCUI 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
N451655089325followed by a unit qualifier and the quantityPackage 51655-0893-25. 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 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5 ) 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 D…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075757
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 10 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2785 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | QPharma Inc | 42708-170 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2790 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 82804-166 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Chartwell RX, LLC | 62135-559 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2859 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8864 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9609 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2868 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-868 |