Prescription drug · ANDA
Lansoprazole DR (Lansoprazole) NDC 80425-0148
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0148-1 | 8042501480180425014801 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0148-1)Marketed from Oct 15, 2010 | |
| 80425-0148-2 | 8042501480280425014802 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0148-2)Marketed from Oct 15, 2010 |
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 DRSuffix: DR
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 15 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0148_2a99c981-daed-71e5-e063-6294a90a5c1dSPL ID 2a99c981-daed-71e5-e063-6294a90a5c1dSPL set ID c77da981-9260-fabd-e053-2a95a90aa71cRxCUI 596843UNII 0K5C5T2QPG
- 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
N480425014801followed by a unit qualifier and the quantityPackage 80425-0148-01. 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)
Indications and Usage Section 1 INDICATIONS AND USAGE 1.1 Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1)]. 1.2 Eradication of H.pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release capsules/amoxicillin/clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulce…
Excerpt only. Read the full label for complete information.
About NDC 80425-0148
- What is NDC 80425-0148?
- 80425-0148 is the product NDC for Lansoprazole DR (lansoprazole), Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lansoprazole DR (Lansoprazole).
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lansoprazole DR?
- 2 other product NDCs are listed under this name. See all Lansoprazole DR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lansoprazole DR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lansoprazole DR | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Direct_Rx | 72189-370 | 72189-0370-30 |
| Lansoprazole DRlansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0174 | 80425-0174-01 |
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 30 mg/1 | Capsule, Delayed releaseOral | Redpharm Drug | 67296-2270 |
| 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 | 71335-2957 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-510 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0058 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Major Pharmaceuticals | 0904-6662 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-6390 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4456 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6830 |
| 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 15 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-111 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-112 |