Over-the-counter drug · ANDA
Lansoprazole NDC 83324-001
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Chain Drug Marketing Association
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83324-001-14 | 83324000114 | 1 BOTTLE in 1 CARTON (83324-001-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from May 18, 2023 |
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 — 15 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202194
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 83324-001_34ab635b-b933-8b1b-0118-8511f82d866bSPL ID 34ab635b-b933-8b1b-0118-8511f82d866bSPL set ID 74417c65-cccd-5a6a-0f96-0d8cb5a1592aRxCUI 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
N483324000114followed by a unit qualifier and the quantityPackage 83324-0001-14. 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)
Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202194
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 | AMERISOURCEBERGEN DRUG CORPORATION | 46122-744 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0612 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Walgreens company | 0363-0037 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Rugby Laboratories, Inc | 0536-1368 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc. | 43598-109 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc. | 43598-161 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-739 |