Over-the-counter drug · NDA
topcare Lansoprazole (Lansoprazole) NDC 36800-295
Lansoprazole 15 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-295-74 | 3680002957436800029574 | 14 BLISTER PACK in 1 CARTON (36800-295-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jun 18, 2020 |
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)
- topcare Lansoprazole
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating, Delayed release
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-295_d6083bce-520b-4c14-bd0f-698e33b4b4f6SPL ID d6083bce-520b-4c14-bd0f-698e33b4b4f6SPL set ID ec5d6d5c-11e7-4932-a48f-fb72218ceccdRxCUI 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
N436800029574followed by a unit qualifier and the quantityPackage 36800-0295-74. 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 36800-295
- What is NDC 36800-295?
- 36800-295 is the product NDC for topcare Lansoprazole (lansoprazole), Lansoprazole 15 mg/1 tablet, orally disintegrating, delayed release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare Lansoprazole (Lansoprazole).
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare Lansoprazole?
- 1 other product NDC are listed under this name. See all topcare Lansoprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare 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) |
|---|---|---|---|---|---|
| topcare lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Topco Associates LLC | 36800-392 | 36800-0392-0136800-0392-03 |
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 |
| Good Sense Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | L. Perrigo Company | 0113-0116 |
| 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 |