Home NDC 71475-257-01 Arakoda
Product NDC 71475-257
Requested package NDC 71475-257-01
11-digit product format 714750257
Labeler code 71475
Product ID 71475-257_661ad23b-4c46-4122-9f6c-06feeb80d95a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tafenoquine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler 60 Degrees Pharmaceuticals, INC.
Application NDA210607
Marketing category NDA
Marketing start 2018-08-20
Substance TAFENOQUINE
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71475-257 71475-257-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 N210607-001 ARAKODA TAFENOQUINE SUCCINATE EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210607-001 10342791 2035-12-02 U-2582 2019-07-31 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 N210607-001 12616689 2035-12-02 U-2582 2026-06-01
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 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210607-001 ARAKODA EQ 100MG BASE TABLET / ORAL RLD, RS 2018-08-08 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 104 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210607-001 12616689 2035-12-02 U-2582 2026-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210607-001 12616689 2035-12-02 U-2582 2026-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210607-001 11744828 2035-12-02 U-2582 2023-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210607-001 10342791 2035-12-02 U-2582 2019-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210607-001 10888558 2035-12-02 U-2582 2021-02-10 79d66fd596c7…
Observed Orange Book exclusivity history# 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 Arakoda
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAFENOQUINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 262P8GS9L9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2054096 Internal RxNorm lookup 2054102 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 71475-257-01 Arakoda 8 in 1 BLISTER PACK TABLET, FILM COATED 8 6 71475-257-01 Arakoda 2 in 1 CARTON TABLET, FILM COATED 2 6 71475-257-02 Arakoda 8 in 1 BOTTLE TABLET, FILM COATED 8 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71475-257 ARAKODA (TAFENOQUINE) TABLET, FILM COATED [60 DEGREES PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20250114_299e49d8-470f-4779-a010-4a1ee0e0c6cd.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 Units Marketing start Marketing end Sample Exclude flag Status 71475-257-01 71475025701 2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2018-08-20 0000-00-00 No No Current