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Kodatef drug information

TAFENOQUINE
60 Degrees Pharmaceuticals, INC · ORAL

Product NDC: 71475-258

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameTAFENOQUINE
Labeler / manufacturer60 Degrees Pharmaceuticals, INC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC71475-258
Label effective date2025-02-10

Official product label reference

Kodatef — 60 Degrees Pharmaceuticals, INC

This page contains 4 source sections for TAFENOQUINE, oral route. Label set 2d808b36-5e84-2825-e063-6394a90a3f9f, version 4.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Malaria prophylaxis, consistent with the approved use of ARAKODA
Dosage and administration — label text
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.
Warnings and precautions
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
Health care provider letter
Dear Healthcare Provider Letter Dear Healthcare Provider Letter pages 1-61 Dear HCP letter page 1 Dear HCP letter page 2 Dear HCP letter page 3 Dear HCP letter page 4 Dear HCP letter page 5 Dear HCP letter page 6 Dear HCP letter page 7 Dear HCP letter page 8 Dear HCP letter page 9 Dear HCP letter page 10 Dear HCP letter page 11 Dear HCP letter page 12 Dear HCP letter page 13 Dear HCP letter page 14 Dear HCP letter page 15 Dear HCP letter page 16 Dear HCP letter page 17 Dear HCP letter page 18 Dear HCP letter page 19 Dear HCP letter page 20 Dear HCP letter page 21 Dear HCP letter page 22 Dear HCP letter page 23 Dear HCP letter page 24 Dear HCP letter page 25 Dear HCP letter page 26 Dear HCP letter page 27 Dear HCP letter page 28 Dear HCP letter page 29 Dear HCP letter page 30 Dear HCP letter page 31 Dear HCP letter page 32 Dear HCP letter page 33 Dear HCP letter page 34 Dear HCP letter page 35 Dear HCP letter page 36 Dear HCP letter page 37 Dear HCP letter page 38 Dear HCP letter page 39 Dear HCP letter page 40 Dear HCP letter page 41 Dear HCP letter page 42 Dear HCP letter page 43 Dear HCP letter page 44 Dear HCP letter page 45 Dear HCP letter page 46 Dear HCP letter page 47 Dear HCP letter page 48 Dear HCP letter page 49 Dear HCP letter page 50 Dear HCP letter page 51 Dear HCP letter page 52 Dear HCP letter page 53 Dear HCP letter page 54 Dear HCP letter page 55 Dear HCP letter page 56 Dear HCP letter page 57 Dear HCP letter page 58 Dear HCP letter page 59 Dear HCP letter page 60 Dear HCP letter page 61

Official sources and product identifiers

Substances listed: TAFENOQUINE

RxNorm identifiers: 2054096, 2705375

Package NDC codes

71475-258-03

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.