Home NDC 0078-0568 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022268-001 COARTEM ARTEMETHER; LUMEFANTRINE 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022268-001 COARTEM 20MG;120MG TABLET / ORAL RLD, RS 2009-04-07 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C7D6T3H22J Internal UNII lookup F38R0JR742 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 847731 Internal RxNorm lookup 847734 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COARTEM ARTEMETHER AND LUMEFANTRINE Novartis Pharmaceuticals Corporation 7866ec19-dfac-47d4-a53f-511a12643cbf 2026-03-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 022268 application number: NDA022268 ndc (product): 0078-0568
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