Home NDC 69539-315 Teriflunomide
Product NDC 69539-315
11-digit product format 695390315
Labeler code 69539
Product ID 69539-315_3b178225-b3ba-4c9f-bde6-a5e076697980
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA209623
Marketing category ANDA
Marketing start 2019-04-24
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 A209623-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 A209623-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24
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 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2019-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2019-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2019-04-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2019-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2019-04-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2019-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2019-04-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2019-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2019-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2019-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2019-04-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2019-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209623-001 TERIFLUNOMIDE 7MG TABLET / ORAL 2019-04-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209623-002 TERIFLUNOMIDE 14MG TABLET / ORAL 2019-04-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
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 69539-315-41 Teriflunomide 14 in 1 BLISTER PACK TABLET, FILM COATED 14 8 69539-315-41 Teriflunomide 2 in 1 CARTON TABLET, FILM COATED 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-315 TERIFLUNOMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] 8 Current NDC, 2 package rows 20230208_63ba28ef-5055-461a-99ef-c49e8ece4b54.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 69539-315-41 69539031541 2 BLISTER PACK in 1 CARTON (69539-315-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-04-24 No No Current