Kodatef

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Kodatef
Generic name: TAFENOQUINE
Manufacturer: 60 Degrees Pharmaceuticals, INC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 2d808b36-5e84-2825-e063-6394a90a3f9f
SPL ID: 2dd1af4c-76f8-d933-e063-6394a90a3931
Version: 4
Effective date: 2025-02-10
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:25:30

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Kodatef	openfda.brand_name
generic name		TAFENOQUINE	openfda.generic_name
manufacturer name		60 Degrees Pharmaceuticals, INC	openfda.manufacturer_name
ndc	package	71475-258-03	openfda.package_ndc
ndc	product	71475-258	openfda.product_ndc
ndc11	package	71475025803	derived:openfda.package_ndc
rxcui		2705375	openfda.rxcui
rxcui		2054096	openfda.rxcui
spl id		2dd1af4c-76f8-d933-e063-6394a90a3931	id
spl set id		2d808b36-5e84-2825-e063-6394a90a3f9f	set_id
unii		262P8GS9L9	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.