Home NDC 69339-169 Teriflunomide
Product NDC 69339-169
11-digit product format 693390169
Labeler code 69339
Product ID 69339-169_70bc9344-abbf-4aca-96c0-7f10cfe9aae4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriflunomide
Dosage form TABLET
Route ORAL
Labeler Natco Pharma USA LLC
Application ANDA209555
Marketing category ANDA
Marketing start 2023-06-17
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 42 .
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 A209555-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 A209555-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15
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 2 · 46 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 2026-08-18 06:07:40 2026-07 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209555-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-05-15 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209555-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-05-15 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 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 69339-169-03 Teriflunomide 30 in 1 BOTTLE TABLET 30 4 69339-169-09 Teriflunomide 90 in 1 BOTTLE TABLET 90 4 69339-169-93 Teriflunomide 2 in 1 CARTON TABLET 2 4 69339-169-93 Teriflunomide 30 in 1 BLISTER PACK TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-169 TERIFLUNOMIDE TABLET [NATCO PHARMA USA LLC] 4 Current NDC, 4 package rows 20240109_8219b4a2-fb9d-4387-ba33-96d28aad71dd.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 69339-169-03 69339016903 30 TABLET in 1 BOTTLE (69339-169-03) 30 tablet 2024-01-02 No No Current 69339-169-09 69339016909 90 TABLET in 1 BOTTLE (69339-169-09) 90 tablet 2024-01-02 No No Current 69339-169-93 69339016993 2 BLISTER PACK in 1 CARTON (69339-169-93) / 30 TABLET in 1 BLISTER PACK 2 blister pack 2023-06-17 No No Current