Prescription drug · ANDA
Lansoprazole NDC 82009-039
Lansoprazole 30 mg/1 · Capsule, Delayed release · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-039-05 | 82009003905 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05)Marketed from Oct 14, 2022 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203083
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 82009-039_2f333840-e837-3207-e063-6294a90aea03SPL ID 2f333840-e837-3207-e063-6294a90aea03SPL set ID cc006372-32d3-4539-921a-6bc9ec496b28RxCUI 311277UNII 0K5C5T2QPGUPC 0382009039053
- 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
N482009003905followed by a unit qualifier and the quantityPackage 82009-0039-05. 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 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 nonsteroidal 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 esophagitis…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203083
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. | 68071-3634 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-570 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-571 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9680 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9693 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2734 |