NDC 0173-0889

Krintafel

Tafenoquine Succinate

Krintafel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Tafenoquine Succinate.

• Product ID: 0173-0889_1ea81964-b3a3-42e1-9d3c-fbd5fed5d921
• NDC: 0173-0889
• Product Type: Human Prescription Drug
• Proprietary Name: Krintafel
• Generic Name: Tafenoquine Succinate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-22
• Marketing Category: NDA / NDA
• Application Number: NDA210795
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: TAFENOQUINE SUCCINATE
• Active Ingredient Strength: 150 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0173-0889-13

30 TABLET, FILM COATED in 1 BOTTLE (0173-0889-13)

• Marketing Start Date: 2019-01-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0889-39 [00173088939]

Krintafel TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210795
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-22

NDC 0173-0889-13 [00173088913]

Krintafel TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210795
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-22

Drug Details

Active Ingredients

Ingredient	Strength
TAFENOQUINE SUCCINATE	150 mg/1

OpenFDA Data

• SPL SET ID: 5cf989d5-36f5-4561-a30b-9fcb9deb6b6a
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • DL5J0B8VSS
• RxNorm Concept Unique ID - RxCUI:
  • 2109233
  • 2109239