| Product NDC: | 0078-0568 |
| Proprietary Name: | COARTEM |
| Non Proprietary Name: | artemether and lumefantrine |
| Active Ingredient(s): | 20; 120 mg/1; mg/1 & nbsp; artemether and lumefantrine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0568 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022268 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090407 |
| Package NDC: | 0078-0568-45 |
| Package Description: | 24 TABLET in 1 BOTTLE (0078-0568-45) |
| NDC Code | 0078-0568-45 |
| Proprietary Name | COARTEM |
| Package Description | 24 TABLET in 1 BOTTLE (0078-0568-45) |
| Product NDC | 0078-0568 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | artemether and lumefantrine |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090407 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | ARTEMETHER; LUMEFANTRINE |
| Strength Number | 20; 120 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Antimalarial [EPC],Antimalarial [EPC] |