KODATEF- tafenoquine tablet, film coated

Kodatef by

Drug Labeling and Warnings

Kodatef by is a Prescription medication manufactured, distributed, or labeled by 60 Degrees Pharmaceuticals, INC, Piramal Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Dear Healthcare Provider Letter

Dear Healthcare Provider Letter pages 1-61

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

Malaria prophylaxis, consistent with the approved use of ARAKODA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KODATEF 
tafenoquine tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71475-258
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TAFENOQUINE (UNII: 262P8GS9L9) (TAFENOQUINE - UNII:262P8GS9L9)	TAFENOQUINE	100 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
IRON OXIDES (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	TQ100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71475-258-03	1 in 1 CARTON; Type 0: Not a Combination Product	02/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		02/20/2025	09/30/2027

Labeler - 60 Degrees Pharmaceuticals, INC (079146968)

Establishment
Name	Address	ID/FEI	Business Operations
Piramal Pharma Limited		919067108	manufacture(71475-258)