FDA.reportPublic FDA data

Kodatef

Product NDC
71475-258
Requested package NDC
71475-258-03
11-digit product format
714750258
Labeler code
71475
Product ID
71475-258_2dd1af4c-76f8-d933-e063-6394a90a3931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tafenoquine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
60 Degrees Pharmaceuticals, INC
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2025-02-20
Marketing end
2027-09-30
Substance
TAFENOQUINE
Active strength
100 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Kodatef

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAFENOQUINE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
262P8GS9L9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2054096Internal RxNorm lookup
2705375Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d808b36-5e84-2825-e063-6394a90a3f9fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
97222f8d-fce6-44ad-b3db-b18798c198acProduct name120181016
4ea6ac43-4fcd-46cf-8d11-c79e5b99f91cProduct name120181002
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71475-258-03Kodatef1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71475-258KODATEF (TAFENOQUINE) TABLET, FILM COATED [60 DEGREES PHARMACEUTICALS, INC]4Current NDC, 1 package rows20250221_2d808b36-5e84-2825-e063-6394a90a3f9f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KodatefTAFENOQUINE60 Degrees Pharmaceuticals, INC2d808b36-5e84-2825-e063-6394a90a3f9f2025-02-10WarningsExact identifier
ndc (package): 71475-258-03
ndc (product): 71475-258
ndc11 (package): 71475025803

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705375Kodatef 100 MG Oral TabletPSN2d808b36-5e84-2825-e063-6394a90a3f9f4
2054096tafenoquine 100 MG Oral TabletPSN2d808b36-5e84-2825-e063-6394a90a3f9f4
2705375tafenoquine 100 MG Oral Tablet [Kodatef]SBD2d808b36-5e84-2825-e063-6394a90a3f9f4
2054096tafenoquine 100 MG Oral TabletSCD2d808b36-5e84-2825-e063-6394a90a3f9f4
2705375Kodatef 100 MG (as tafenoquine succinate 125.5 MG ) Oral TabletSY2d808b36-5e84-2825-e063-6394a90a3f9f4
2705375Kodatef 100 MG Oral TabletSY2d808b36-5e84-2825-e063-6394a90a3f9f4
2054096tafenoquine (as tafenoquine succinate) 100 MG Oral TabletSY2d808b36-5e84-2825-e063-6394a90a3f9f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71475-258-03714750258031 TABLET, FILM COATED in 1 CARTON (71475-258-03) 2025-02-202027-09-30NoNoHistorical