coartem

Generic: artemether and lumefantrine

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name coartem
Generic Name artemether and lumefantrine
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

artemether 20 mg/1, lumefantrine 120 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0568
Product ID 0078-0568_3890be50-58ca-4301-91c4-5e8ab19923ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022268
Listing Expiration 2026-12-31
Marketing Start 2009-04-07

Pharmacologic Class

Established (EPC)
antimalarial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780568
Hyphenated Format 0078-0568

Supplemental Identifiers

RxCUI
847731 847734
UNII
C7D6T3H22J F38R0JR742
NUI
N0000175482

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name coartem (source: ndc)
Generic Name artemether and lumefantrine (source: ndc)
Application Number NDA022268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 24 TABLET in 1 BOTTLE (0078-0568-45)
source: ndc

Packages (1)

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

Ingredients (2)

artemether (20 mg/1) lumefantrine (120 mg/1)

Linked Drug Pages (1)

COARTEM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3890be50-58ca-4301-91c4-5e8ab19923ad", "openfda": {"nui": ["N0000175482"], "unii": ["C7D6T3H22J", "F38R0JR742"], "rxcui": ["847731", "847734"], "spl_set_id": ["7866ec19-dfac-47d4-a53f-511a12643cbf"], "pharm_class_epc": ["Antimalarial [EPC]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 TABLET in 1 BOTTLE (0078-0568-45)", "package_ndc": "0078-0568-45", "marketing_start_date": "20090407"}], "brand_name": "COARTEM", "product_id": "0078-0568_3890be50-58ca-4301-91c4-5e8ab19923ad", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]"], "product_ndc": "0078-0568", "generic_name": "artemether and lumefantrine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COARTEM", "active_ingredients": [{"name": "ARTEMETHER", "strength": "20 mg/1"}, {"name": "LUMEFANTRINE", "strength": "120 mg/1"}], "application_number": "NDA022268", "marketing_category": "NDA", "marketing_start_date": "20090407", "listing_expiration_date": "20261231"}