Prescription drug · ANDA
Omeprazole NDC 68382-412
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-412-01 | 68382041201 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-01)Marketed from Nov 23, 2012 | |
| 68382-412-05 | 68382041205 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-05)Marketed from Nov 23, 2012 | |
| 68382-412-06 | 68382041206 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-06)Marketed from Nov 23, 2012 | |
| 68382-412-10 | 68382041210 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-10)Marketed from Nov 23, 2012 | |
| 68382-412-16 | 68382041216 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-16)Marketed from Nov 23, 2012 |
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 091352
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 68382-412_d0074baa-52cb-4039-9bd8-966a36ff70daSPL ID d0074baa-52cb-4039-9bd8-966a36ff70daSPL set ID 9c22ceb2-2c34-43c3-9a35-2589c9078741RxCUI 198051, 199119, 200329UNII KG60484QX9UPC 0368382411013, 0368382500014
- 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
N468382041201followed by a unit qualifier and the quantityPackage 68382-0412-01. 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 delayed-release capsules are 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 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older ( 1.5 ) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duode…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091352
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 | A-S Medication Solutions | 50090-7018 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7019 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7021 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Major Pharmaceuticals | 0904-6917 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 65841-759 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 65841-760 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 65841-761 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Cardinal Health 107, LLC | 55154-2332 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9744 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-411 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-500 |