NDC 0078-0568

COARTEM

Artemether And Lumefantrine

COARTEM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Artemether; Lumefantrine.

• Product ID: 0078-0568_16e16be7-74d6-4386-9261-3abaf63f0805
• NDC: 0078-0568
• Product Type: Human Prescription Drug
• Proprietary Name: COARTEM
• Generic Name: Artemether And Lumefantrine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-04-07
• Marketing Category: NDA / NDA
• Application Number: NDA022268
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: ARTEMETHER; LUMEFANTRINE
• Active Ingredient Strength: 20 mg/1; mg/1
• Pharm Classes: Antimalarial [EPC],Antimalarial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0568-45

24 TABLET in 1 BOTTLE (0078-0568-45)

• Marketing Start Date: 2009-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0568-45 [00078056845]

COARTEM TABLET

• Marketing Category: NDA
• Application Number: NDA022268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-04-07

Drug Details

Active Ingredients

Ingredient	Strength
ARTEMETHER	20 mg/1

OpenFDA Data

• SPL SET ID: 7866ec19-dfac-47d4-a53f-511a12643cbf
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • F38R0JR742
  • C7D6T3H22J
• RxNorm Concept Unique ID - RxCUI:
  • 847734
  • 847731

Pharmacological Class

• Antimalarial [EPC]
• Antimalarial [EPC]

NDC Crossover Matching brand name "COARTEM" or generic name "Artemether And Lumefantrine"

NDC	Brand Name	Generic Name
0078-0568	COARTEM	artemether and lumefantrine
76413-154	COARTEM	artemether and lumefantrine