FDA.reportPublic FDA data

Arakoda

Product NDC
71475-257
11-digit product format
714750257
Labeler code
71475
Product ID
71475-257_661ad23b-4c46-4122-9f6c-06feeb80d95a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tafenoquine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
60 Degrees Pharmaceuticals, INC.
Application
NDA210607
Marketing category
NDA
Marketing start
2018-08-20
Substance
TAFENOQUINE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arakoda
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAFENOQUINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii262P8GS9L9
Rxcui2054096, 2054102

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
71475-257-01Arakoda8 in 1 BLISTER PACKTABLET, FILM COATED86
71475-257-01Arakoda2 in 1 CARTONTABLET, FILM COATED26
71475-257-02Arakoda8 in 1 BOTTLETABLET, FILM COATED86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71475-257-01EA - Each71475-257fbd1e209-d093-4c17-8d6b-ecf7deb1ee6012018-11-06
71475-257-02EA - Each71475-257ade8b512-17b6-4588-b1d2-5e0fbb44356d12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71475-257ARAKODA (TAFENOQUINE) TABLET, FILM COATED [60 DEGREES PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20250114_299e49d8-470f-4779-a010-4a1ee0e0c6cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054102Arakoda 100 MG Oral TabletPSN299e49d8-470f-4779-a010-4a1ee0e0c6cd6
2054096tafenoquine 100 MG Oral TabletPSN299e49d8-470f-4779-a010-4a1ee0e0c6cd6
2054102tafenoquine 100 MG Oral Tablet [Arakoda]SBD299e49d8-470f-4779-a010-4a1ee0e0c6cd6
2054096tafenoquine 100 MG Oral TabletSCD299e49d8-470f-4779-a010-4a1ee0e0c6cd6
2054102Arakoda 100 MG Oral TabletSY299e49d8-470f-4779-a010-4a1ee0e0c6cd6
2054096tafenoquine (as tafenoquine succinate) 100 MG Oral TabletSY299e49d8-470f-4779-a010-4a1ee0e0c6cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71475-257-01714750257012 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-08-200000-00-00NoNoCurrent
71475-257-02714750257028 TABLET, FILM COATED in 1 BOTTLE (71475-257-02) 2018-08-200000-00-00NoNoCurrent