Home NDC 0378-0627 Teriflunomide
Product NDC 0378-0627
11-digit product format 003780627
Labeler code 0378
Product ID 0378-0627_1824aae5-58af-43da-8231-435c8f118bc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA209702
Marketing category ANDA
Marketing start 2023-02-14
Substance TERIFLUNOMIDE
Active strength 7 mg/1
Pharmacologic classes Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
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 A209702-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 A209702-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28
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 · 74 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 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209702-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2020-02-28 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209702-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2020-02-28 87673890dc5c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Teriflunomide
Listing expiration 2026-12-31 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 0378-0627-93 Teriflunomide 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0627 TERIFLUNOMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 Current NDC, 1 package rows 20230215_1824aae5-58af-43da-8231-435c8f118bc0.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 Marketing start Sample Exclude flag Status 0378-0627-93 00378062793 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0627-93) 2023-03-31 No No Current