Prescription drug · ANDA
Omeprazole NDC 63187-170
Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-170-30 | 63187017030 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-30)Marketed from Jan 1, 2019 | |
| 63187-170-60 | 63187017060 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-60)Marketed from Jan 1, 2019 | |
| 63187-170-90 | 63187017090 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-90)Marketed from Jan 1, 2019 |
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
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076048
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-170_145db374-f2b5-40e4-8801-435b802c9b77SPL ID 145db374-f2b5-40e4-8801-435b802c9b77SPL set ID 253451a6-02a9-4b27-aed7-f3dbc2e09682RxCUI 200329UNII KG60484QX9UPC 0363187170301
- 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
N463187017030followed by a unit qualifier and the quantityPackage 63187-0170-30. 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 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 in pediatric patients <1 year of age have not been established. ( 8.4 ) 1.1 Duodenal Ulcer (adults) Omeprazole delayed-release capsules, USP are 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 capsules, USP, in combination with clarithr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076048
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 | Bryant Ranch Prepack | 71335-1395 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-3952 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0569 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-248 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1636 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-0065 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-061 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-0146 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-0145 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-070 |