Prescription drug · ANDA
Lansoprazole NDC 63187-510
Lansoprazole 30 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-510-30 | 63187051030 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-510-30)Marketed from Jul 1, 2015 | |
| 63187-510-60 | 63187051060 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-510-60)Marketed from Jul 1, 2015 | |
| 63187-510-90 | 63187051090 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-510-90)Marketed from Jul 1, 2015 |
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)
- Lansoprazole
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 30 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 091269
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-510_06664186-1f92-44f3-b25e-97f1f6a539eaSPL ID 06664186-1f92-44f3-b25e-97f1f6a539eaSPL set ID 3e3e63df-e2ad-420b-acb9-28e65ea6fb07RxCUI 311277UNII 0K5C5T2QPGUPC 0363187510305
- 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
N463187051030followed by a unit qualifier and the quantityPackage 63187-0510-30. 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)
Lansoprazole delayed-release capsule is a proton pump inhibitor (PPI) indicated for: • Short-Term Treatment of Active Duodenal Ulcer ( 1.1 ) • H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.2) • Maintenance of Healed Duodenal Ulcers ( 1.3) • Short-Term Treatment of Active Benign Gastric Ulcer (1.4) • Healing of nonsteroidal anti-inflammatory drugs (NSAID)-Associated Gastric Ulcer ( 1.5 ) • Risk Reduction of NSAID-Associated Gastric Ulcer (1.6) • Gastroesophageal Reflux Disease (GERD) ( 1.7 ) • Maintenance of Healing of Erosive Esophagitis (EE) ( 1.8 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) ( 1.9 ) 1.1 Short-Term Treatment…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091269
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 |
|---|---|---|---|---|
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4456 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-112 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-111 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-111 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-123 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3687 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6830 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2957 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Major Pharmaceuticals | 0904-6662 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-398 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-399 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0058 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Redpharm Drug | 67296-2270 |
| Lansoprazole DRlansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0148 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-6390 |