Prescribing information (package insert) - Kodatef
Hemolytic Anemia
G6PD Deficiency in Pregnancy and Lactation
Methemoglobinemia
Psychiatric Effects
Hypersensitivity Reactions
Delayed Adverse Reactions, Including Hemolytic Anemia, Methemoglobinemia, Psychiatric Effects, and Hypersensitivity Reactions
Loading Dose: 200 mg (two of the 100 mg filmcoated tablets) once daily for three days.
Maintenance Dose: 200 mg (two of the 100 mg filmcoated tablets) once weekly – start seven days after the last loading dose.
Malaria prophylaxis, consistent with the approved use of ARAKODA
About this document
Source: FDA drug labeling via NLM DailyMed
· View the label on DailyMed
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Drug information for Kodatef
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Active ingredient |
Tafenoquine 100 mg
|
| Dosage form |
Tablet, film coated |
| Route |
Oral |
| Marketing status |
listed in the FDA NDC Directory |
| Company (applicant) |
60 Degrees Pharmaceuticals, INC |
| FDA approval |
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
|
| Manufacturers |
1 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
100 mg – 1 in 1 carton
NDC 71475-258-03
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
