Home NDC 68462-311-84 teriflunomide
Product NDC 68462-311
Requested package NDC 68462-311-84
11-digit product format 684620311
Labeler code 68462
Product ID 68462-311_547ff1b7-72fc-4820-b337-d8ee0202fefe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name teriflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA209663
Marketing category ANDA
Marketing start 2020-05-01
Marketing end 0000-00-00
Substance TERIFLUNOMIDE
Active strength 7 mg/1
Pharmacologic classes Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A209663-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 A209663-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15
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 · 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 2026-02-19 14:30 UTC 2026-02 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209663-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2018-11-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209663-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2018-11-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join teriflunomide TERIFLUNOMIDE Glenmark Pharmaceuticals Inc., USA cb431ea0-ba0f-4b5d-a50d-f8c050762242 2026-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209663 application number: ANDA209663
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-311-84 68462031184 2 BLISTER PACK in 1 CARTON (68462-311-84) > 14 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2020-05-01 0000-00-00 No No Current