Home NDC 16714-059 Febuxostat
Product NDC 16714-059
11-digit product format 167140059
Labeler code 16714
Product ID 16714-059_0284b7a5-7a1f-4e37-9883-b7bdba68c42b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Febuxostat
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NorthStar RxLLC
Application ANDA205467
Marketing category ANDA
Marketing start 2021-01-26
Substance FEBUXOSTAT
Active strength 40 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205467-001 FEBUXOSTAT FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 A205467-002 FEBUXOSTAT FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 of 3 · 82 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 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 e64feba35796…2022-09-29 23:25 UTC 2022-09 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205467-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-07-01 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205467-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-07-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Febuxostat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEBUXOSTAT 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 101V0R1N2E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 834235 Internal RxNorm lookup 834241 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 16714-059-01 Febuxostat 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-059 FEBUXOSTAT TABLET, FILM COATED [NORTHSTAR RXLLC] 2 Current NDC, Legacy NDC, 1 package rows 20231122_ad40e0f6-850c-429a-87fc-f1eb2361e962.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Febuxostat FEBUXOSTAT NuCare Pharmaceuticals, Inc. 2b5cf14a-6c5f-1eb2-e063-6294a90aaac8 2025-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205467 application number: ANDA205467 Febuxostat FEBUXOSTAT American Health Packaging 14f80ad5-37cc-4672-9caa-2dd2f469af0a 2024-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205467 application number: ANDA205467 Febuxostat FEBUXOSTAT NorthStar RxLLC ad40e0f6-850c-429a-87fc-f1eb2361e962 2023-11-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205467 application number: ANDA205467 ndc (product): 16714-059 Febuxostat FEBUXOSTAT Sun Pharmaceutical Industries, Inc. 1f7541bd-bf32-422b-b99a-89193cf193ca 2023-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205467 application number: ANDA205467
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 16714-059-01 16714005901 30 TABLET, FILM COATED in 1 BOTTLE (16714-059-01) 2021-01-26 0000-00-00 No No Current