Prescription drug · ANDA
Omeprazole NDC 43353-829
Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-829-60 | 43353082960 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60)Marketed from Mar 25, 2013 | |
| 43353-829-80 | 43353082980 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80)Marketed from Nov 11, 2020 |
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 — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075410
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 43353-829_1b00384a-efea-458c-8485-5da3db9d28d6SPL ID 1b00384a-efea-458c-8485-5da3db9d28d6SPL set ID 4b188d97-f1b3-468d-9818-b8333bf24b5aRxCUI 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
N443353082960followed by a unit qualifier and the quantityPackage 43353-0829-60. 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 is a proton pump inhibitor indicated for: Treatment in adults of duodenal ulcer ( 1.1 ) and gastric ulcer ( 1.2 ). Treatment in adults and children of gastroesophageal reflux disease (GERD) ( 1.3 ) and maintenance of healing of erosive esophagitis ( 1.4 ). The safety and effectiveness of Omeprazole Delayed-Release Capsules in pediatric patients < 1 year of age have not been established ( 8.4 ). 1.1 Duodenal Ulcer (adults) Omeprazole Delayed-Release Capsules is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole Delayed-Release …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075410
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 | NuCare Pharmaceuticals,Inc. | 68071-2243 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1532 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-157 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-155 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Chartwell RX, LLC | 62135-530 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4906 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4025 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Lannett Company, Inc. | 62175-114 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Lannett Company, Inc. | 62175-118 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Lannett Company, Inc. | 62175-136 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1746 |