Prescription drug · NDA
Coartem NDC 0078-0568
artemether and lumefantrine · Artemether 20 mg/1; Lumefantrine 120 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0568-45 | 00078056845 | 24 TABLET in 1 BOTTLE (0078-0568-45)Marketed from Apr 7, 2009 |
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)
- Coartem
- Generic name (nonproprietary)
- artemether and lumefantrine
- Active ingredients
- Artemether — 20 mg/1Lumefantrine — 120 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022268
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-0568_d8b344bc-882f-4f60-8593-8c6ed1a11919SPL ID d8b344bc-882f-4f60-8593-8c6ed1a11919SPL set ID 7866ec19-dfac-47d4-a53f-511a12643cbfRxCUI 847731, 847734UNII C7D6T3H22J, F38R0JR742
- Pharmacologic class
- Antimalarial
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
N400078056845followed by a unit qualifier and the quantityPackage 00078-0568-45. 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)
Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. Coartem Tablets are a combination of artemether and lumefantrine, both antimalarials, indicated for treatment of acute, uncomplicated malaria infections due t…
Excerpt only. Read the full label for complete information.