Home NDC 82249-111 Teriflunomide
Product NDC 82249-111
11-digit product format 822490111
Labeler code 82249
Product ID 82249-111_5e7f1c5f-435f-edeb-e063-6294a90a03db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Civica Script LLC
Application ANDA209598
Marketing category ANDA
Marketing start 2026-10-26
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 44 .
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 A209598-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 A209598-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13
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 2 · 52 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 2026-10-15 13:18:30 2026-09 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209598-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A209598-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 52 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 Teriflunomide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERIFLUNOMIDE 7 mg/1
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 Camber Pharmaceuticals, Inc. 9b25c24e-a4a9-43b4-a33f-75bef3a96d5f 2023-03-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209598 application number: ANDA209598
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82249-111-30 82249011130 30 TABLET, FILM COATED in 1 BOTTLE (82249-111-30) 2026-10-26 No No Current