Over-the-counter drug · NDA
Good Sense Lansoprazole (Lansoprazole) NDC 0113-0116
Lansoprazole 15 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · L. Perrigo Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0113-0116-55 | 0011301165500113011655 | 3 CARTON in 1 CARTON (0113-0116-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Nov 28, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Good Sense Lansoprazole
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating, Delayed release
- Route
- Oral
- Labeler
- L. Perrigo CompanyNDC labeler code 0113
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208025
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0113-0116_a5e0ac07-7297-4c43-b706-94b5c9d94481SPL ID a5e0ac07-7297-4c43-b706-94b5c9d94481SPL set ID d86585b7-e146-4f04-9016-412b16e06f55RxCUI 351261UNII 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
N400113011655followed by a unit qualifier and the quantityPackage 00113-0116-55. 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.
About NDC 0113-0116
- What is NDC 0113-0116?
- 0113-0116 is the product NDC for Good Sense Lansoprazole (lansoprazole), Lansoprazole 15 mg/1 tablet, orally disintegrating, delayed release, listed with the FDA by L. Perrigo Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Good Sense Lansoprazole (Lansoprazole).
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Good Sense Lansoprazole?
- 1 other product NDC are listed under this name. See all Good Sense Lansoprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Good Sense 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) |
|---|---|---|---|---|---|
| Good Sense Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | L. Perrigo Company | 0113-1114 | 00113-1114-0100113-1114-0200113-1114-03 |
Other NDCs under NDA 208025
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 |
|---|---|---|---|---|
| basic care lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-829 |
| equate lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Wal-Mart Stores Inc | 49035-373 |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Walgreen Company | 0363-1419 |
| lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Kroger Company | 30142-192 |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | CVS Pharmacy | 69842-507 |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-672 |
| topcare Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Topco Associates LLC | 36800-295 |