Home NDC 0173-0889 Krintafel
Product NDC 0173-0889
11-digit product format 001730889
Labeler code 0173
Product ID 0173-0889_d400b994-abe7-40a6-a7bd-0fbf45f855ad
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210795-001 KRINTAFEL EQ 150MG BASE TABLET / ORAL RLD, RS 2018-07-20 f41ea6bd6efb…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 63 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
openFDA label cross-check# 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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