What is NDC 0078-0568?

0078-0568 is the product NDC for Coartem, Artemether 20 mg/1; Lumefantrine 120 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Coartem (Artemether and lumefantrine).

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Coartem?

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.

Coartem NDC 0078-0568 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0568Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
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
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022268
Marketing start: Apr 7, 2009
Listing expires: Dec 31, 2027
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

N400078056845 followed by a unit qualifier and the quantity

Package 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 Mar 26, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0568

What is NDC 0078-0568?: 0078-0568 is the product NDC for Coartem, Artemether 20 mg/1; Lumefantrine 120 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Coartem (Artemether and lumefantrine).
What is the active ingredient?: Artemether, Lumefantrine.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Coartem?: 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.

Coartem (Artemether and lumefantrine) NDC 0078-0568