Prescription drug · ANDA
Omeprazole NDC 60760-833
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · St. Mary's Medical Park Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-833-30 | 60760083330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-833-30)Marketed from Jul 30, 2024 |
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 075576
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 60760-833_55008f08-bf88-2b54-e063-6394a90aed9cSPL ID 55008f08-bf88-2b54-e063-6394a90aed9cSPL set ID 1eb57c13-25ed-70bc-e063-6294a90afdacRxCUI 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
N460760083330followed by a unit qualifier and the quantityPackage 60760-0833-30. 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 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 patie…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075576
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 | NorthStar Rx LLC | 16714-714 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0332 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 51655-061 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-157 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-158 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-159 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quality Care Products, LLC | 49999-265 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-805 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-1157 |
| Omeprazole DRomeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0071 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-743 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-022 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0415 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | QPharma, Inc. | 42708-158 |