Home NDC 0173-0889 Krintafel
Product NDC 0173-0889
11-digit product format 001730889
Labeler code 0173
Product ID 0173-0889_ebe22603-a38f-475d-a2b6-9ffe00dbcd23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tafenoquine succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA210795
Marketing category NDA
Marketing start 2019-01-22
Substance TAFENOQUINE SUCCINATE
Active strength 150 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210795-001 KRINTAFEL TAFENOQUINE SUCCINATE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Krintafel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAFENOQUINE SUCCINATE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DL5J0B8VSS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2109233 Internal RxNorm lookup 2109239 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0173-0889-39 Krintafel 2 in 1 BOTTLE TABLET, FILM COATED 2 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0889 KRINTAFEL (TAFENOQUINE SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 11 Current NDC, Legacy NDC, 1 package rows 20240705_5cf989d5-36f5-4561-a30b-9fcb9deb6b6a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0173-0889-13 00173088913 30 TABLET, FILM COATED in 1 BOTTLE (0173-0889-13) 2019-01-22 0000-00-00 No No Current 0173-0889-39 00173088939 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39) 2019-01-22 0000-00-00 No No Current