NDC 76413-154
COARTEM
Artemether And Lumefantrine
COARTEM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Central Texas Community Health Centers. The primary component is Artemether; Lumefantrine.
| Product ID | 76413-154_2e678bdb-4af9-4937-800f-8165778b0fe4 |
| NDC | 76413-154 |
| 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 | Central Texas Community Health Centers |
| 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 | 2019-12-31 |
Packaging
NDC 76413-154-06
6 TABLET in 1 BOTTLE, PLASTIC (76413-154-06)
| Marketing Start Date | 2009-04-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 76413-154-12 [76413015412]
COARTEM TABLET
| Marketing Category | NDA |
| Application Number | NDA022268 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-04-07 |
| Inactivation Date | 2020-01-31 |
NDC 76413-154-06 [76413015406]
COARTEM TABLET
| Marketing Category | NDA |
| Application Number | NDA022268 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-04-07 |
| Inactivation Date | 2020-01-31 |
NDC 76413-154-24 [76413015424]
COARTEM TABLET
| Marketing Category | NDA |
| Application Number | NDA022268 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-04-07 |
| Inactivation Date | 2020-01-31 |
NDC 76413-154-18 [76413015418]
COARTEM TABLET
| Marketing Category | NDA |
| Application Number | NDA022268 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-04-07 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ARTEMETHER | 20 mg/1 |
OpenFDA Data
| SPL SET ID: | 66e02264-6917-4185-9c36-9dc64eaaeb23 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [COARTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COARTEM 78678097 not registered Dead/Abandoned |
Novartis AG 2005-07-26 |
 COARTEM 77646579 3713280 Live/Registered |
Novartis AG 2009-01-09 |
 COARTEM 75345324 not registered Dead/Abandoned |
NOVARTIS AG 1997-08-22 |
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