COARTEM
- Product NDC
- 0078-0568
- 11-digit product format
- 000780568
- Labeler code
- 0078
- Product ID
- 0078-0568_d8b344bc-882f-4f60-8593-8c6ed1a11919
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- artemether and lumefantrine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA022268
- Marketing category
- NDA
- Marketing start
- 2009-04-07
- Substance
- ARTEMETHER; LUMEFANTRINE
- Active strength
- 20; 120 mg/1; mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antimalarial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COARTEM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARTEMETHER | 20 mg/1 |
| LUMEFANTRINE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C7D6T3H22J, F38R0JR742 |
| Rxcui | 847731, 847734 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0568-45 | COARTEM | 24 in 1 BOTTLE | TABLET | 24 | | 25 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0568 | COARTEM (ARTEMETHER AND LUMEFANTRINE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] | 23 | Current NDC, Legacy NDC, 1 package rows | 20241120_7866ec19-dfac-47d4-a53f-511a12643cbf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0568-45 | 00078056845 | 24 TABLET in 1 BOTTLE (0078-0568-45) | 24 tablet | 2009-04-07 | 0000-00-00 | No | No | Current |