NDC 71475-257

Arakoda

Tafenoquine

Arakoda is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by 60 Degrees Pharmaceuticals, Llc. The primary component is Tafenoquine.

• Product ID: 71475-257_14792adc-cc7f-4c42-a815-d3d03f6e94d1
• NDC: 71475-257
• Product Type: Human Prescription Drug
• Proprietary Name: Arakoda
• Generic Name: Tafenoquine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-20
• Marketing Category: NDA / NDA
• Application Number: NDA210607
• Labeler Name: 60 Degrees Pharmaceuticals, LLC
• Substance Name: TAFENOQUINE
• Active Ingredient Strength: 100 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71475-257-01

2 BLISTER PACK in 1 CARTON (71475-257-01) > 8 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-08-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71475-257-01 [71475025701]

Arakoda TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210607
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-20

Drug Details

Active Ingredients

Ingredient	Strength
TAFENOQUINE	100 mg/1

OpenFDA Data

• SPL SET ID: 299e49d8-470f-4779-a010-4a1ee0e0c6cd
• Manufacturer:
  • 60 Degrees Pharmaceuticals, LLC
• UNII:
  • 262P8GS9L9
• RxNorm Concept Unique ID - RxCUI:
  • 2054096
  • 2054102