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 pages 1-61
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.
Malaria prophylaxis, consistent with the approved use of ARAKODA
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2705375 | Kodatef 100 MG Oral Tablet | PSN | 4 |
| 2054096 | tafenoquine 100 MG Oral Tablet | PSN | 4 |
| 2705375 | tafenoquine 100 MG Oral Tablet [Kodatef] | SBD | 4 |
| 2054096 | tafenoquine 100 MG Oral Tablet | SCD | 4 |
| 2705375 | Kodatef 100 MG (as tafenoquine succinate 125.5 MG ) Oral Tablet | SY | 4 |
| 2705375 | Kodatef 100 MG Oral Tablet | SY | 4 |
| 2054096 | tafenoquine (as tafenoquine succinate) 100 MG Oral Tablet | SY | 4 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 97222f8d-fce6-44ad-b3db-b18798c198ac | Product name | 1 | 20181016 |
| 4ea6ac43-4fcd-46cf-8d11-c79e5b99f91c | Product name | 1 | 20181002 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71475-258-03 | Kodatef | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71475-258 | 71475-258-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | IACT |
| IRON OXIDES | 1K09F3G675 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TAFENOQUINE | 262P8GS9L9 | ACTIB |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kodatef | TAFENOQUINE | 60 Degrees Pharmaceuticals, INC | 2d808b36-5e84-2825-e063-6394a90a3f9f | 2025-02-10 | Warnings | 71475-258-03 71475-258 71475025803 2dd1af4c-76f8-d933-e063-6394a90a3931 2d808b36-5e84-2825-e063-6394a90a3f9f |
Adverse event summaries are temporarily unavailable. Other product information remains available.