Prescription drug · ANDA
Lansoprazole NDC 63187-152
Lansoprazole 30 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-152-30 | 63187015230 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-152-30)Marketed from Jan 1, 2019 |
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 LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077255
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-152_0ca90194-0255-4661-896a-e066e593bf8aSPL ID 0ca90194-0255-4661-896a-e066e593bf8aSPL set ID 7d811f01-f0c2-4753-bb36-80b48dabb58cRxCUI 311277UNII 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
N463187015230followed by a unit qualifier and the quantityPackage 63187-0152-30. 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 is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage. ( 1 ) 1.1 Short-Term Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [ see Clinical Studies ( 14 ) ]. 1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release capsules USP/amoxicillin/clarithromycin Lansoprazole delayed-release capsules USP in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infectio…
Excerpt only. Read the full label for complete information.
About NDC 63187-152
- What is NDC 63187-152?
- 63187-152 is the product NDC for Lansoprazole, Lansoprazole 30 mg/1 capsule, delayed release, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lansoprazole.
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 94 other product NDCs are listed under this name. See all Lansoprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lansoprazole 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 | Lansoprazole 30 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Cardinal Health 107, LLC | 55154-8340 | 55154-8340-00 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed release pelletsOral | Preferred Pharmaceuticals Inc. | 68788-4141 | 68788-4141-0368788-4141-0668788-4141-09 |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-672 | 72288-0672-55 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-827 | 72288-0827-03 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed release pelletsOral | Safecor Health LLC | 48433-051 | 48433-0051-08 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Medcore LLC | 82461-713 | 82461-0713-30 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-310 | 33342-0310-07 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-311 | 33342-0311-07 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8621 | 68788-8621-0168788-8621-0368788-8621-06+2 more |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Aurobindo Pharma Limited | 65862-895 | 65862-0895-78 |
Other NDCs under ANDA 077255
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 | Teva Pharmaceuticals USA, Inc. | 0093-7350 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7351 |