Prescription drug · ANDA
Lansoprazole NDC 68071-2274
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2274-6 | 68071227406 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2274-6)Marketed from Oct 8, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 15 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205868
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2274_1d76957a-bafe-0eb0-e063-6294a90aaaddSPL ID 1d76957a-bafe-0eb0-e063-6294a90aaaddSPL set ID b12cca1c-da28-67e2-e053-2a95a90aaf6bRxCUI 596843UNII 0K5C5T2QPGUPC 0368071227468
- 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
N468071227406followed by a unit qualifier and the quantityPackage 68071-2274-06. 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)
1. INDICATIONS AND USAGE Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Maintenance of healed duodenal ulcers in adults ( 1.3 ) Treatment of active benign gastric ulcer in adults ( 1.4 ) Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults( 1.6 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7 ) Treatment of erosive esophagiti…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205868
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. | 68071-3633 |
| Lansoprazole DRlansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0174 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-5119 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1425 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6079 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7742 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Lifestar Pharma LLC. | 70756-806 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Lifestar Pharma LLC. | 70756-807 |
| Lansoprazole DR | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Direct_Rx | 72189-370 |