Home NDC 70377-018-11 Teriflunomide
Product NDC 70377-018
Requested package NDC 70377-018-11
11-digit product format 703770018
Labeler code 70377
Product ID 70377-018_bc87e96a-ce9e-58b8-883a-6c9166987103
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Biocon Pharma Inc.
Application ANDA209639
Marketing category ANDA
Marketing start 2023-03-13
Substance TERIFLUNOMIDE
Active strength 14 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 45 .
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 A209639-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 A209639-002 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 · 54 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 2026-11-14 07:37:17 2026-10 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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 14 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 70377-018-11 Teriflunomide 30 in 1 BOTTLE TABLET, FILM COATED 30 9 70377-018-91 Teriflunomide 14 in 1 BLISTER PACK TABLET, FILM COATED 14 9 70377-018-91 Teriflunomide 2 in 1 CARTON TABLET, FILM COATED 2 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70377-018 TERIFLUNOMIDE (TERIFLUNOMIDE) TABLET, FILM COATED [BIOCON PHARMA INC.] 8 Current NDC, 3 package rows 20230331_37f04f8b-001e-66ff-4574-cc34cebce61c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70377-018-11 70377001811 30 TABLET, FILM COATED in 1 BOTTLE (70377-018-11) 2023-03-13 No No Current