Home NDC 59651-054 Teriflunomide
Product NDC 59651-054
11-digit product format 596510054
Labeler code 59651
Product ID 59651-054_86f959a1-cb2b-4df4-b530-094eb486e1d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriflunomide
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA209638
Marketing category ANDA
Marketing start 2023-02-28
Substance TERIFLUNOMIDE
Active strength 7 mg/1
Pharmacologic classes Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
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 42 .
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 A209638-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 A209638-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26
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 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-10-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2018-10-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2018-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2018-10-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2018-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2018-10-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2018-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2018-10-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2018-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209638-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2018-10-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209638-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2018-10-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A209638-001 PC 2023-09-08 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A209638-002 PC 2023-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209638-001 PC 2023-09-08 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209638-002 PC 2023-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209638-001 PC 2023-09-08 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209638-002 PC 2023-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209638-001 PC 2023-09-08 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209638-002 PC 2023-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209638-001 PC 2023-09-08 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209638-002 PC 2023-09-08 3f0d92c62455…
Additional Listing Data#
Finished product Yes
Brand name base Teriflunomide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERIFLUNOMIDE 7 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1C058IKG3B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1310525 Internal RxNorm lookup 1310533 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 59651-054-28 Teriflunomide 14 in 1 BLISTER PACK TABLET 14 7 59651-054-28 Teriflunomide 2 in 1 CARTON TABLET 2 7 59651-054-30 Teriflunomide 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-054 TERIFLUNOMIDE TABLET [AUROBINDO PHARMA LIMITED] 6 Current NDC, 3 package rows 20241107_2fd80242-c607-4c50-b497-8259abb4a2f8.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 Sample Exclude flag Status 59651-054-28 59651005428 2 BLISTER PACK in 1 CARTON (59651-054-28) / 14 TABLET in 1 BLISTER PACK 2 blister pack 2023-02-28 No No Current 59651-054-30 59651005430 30 TABLET in 1 BOTTLE (59651-054-30) 30 tablet 2023-02-28 No No Current