Prescription drug · ANDA
Lansoprazole, Amoxicillin, Clarithromycin NDC 57237-001
Kit · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-001-14 | 5723700011457237000114 | 14 BLISTER PACK in 1 CARTON (57237-001-14) / 1 KIT in 1 BLISTER PACK (57237-001-01)Marketed from Oct 14, 2016 |
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, Amoxicillin, Clarithromycin
- Generic name (nonproprietary)
- lansoprazole, amoxicillin, clarithromycin
- Dosage form
- Kit
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 57237
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206006
- Marketing start
- Listing expires
- Identifiers
- Product ID 57237-001_bca6d415-61f6-4758-91fc-964d1e40c81bSPL ID bca6d415-61f6-4758-91fc-964d1e40c81bSPL set ID 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00RxCUI 197517, 308191, 311277, 757968
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N457237000114followed by a unit qualifier and the quantityPackage 57237-0001-14. 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)
INDICATIONS AND USAGE H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The components in lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets and other anti…
Excerpt only. Read the full label for complete information.
About NDC 57237-001
- What is NDC 57237-001?
- 57237-001 is the product NDC for Lansoprazole, Amoxicillin, Clarithromycin kit, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lansoprazole, Amoxicillin, Clarithromycin.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 57237. 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, Amoxicillin, Clarithromycin?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.