Home NDC 50268-478 LEFLUNOMIDE
Product NDC 50268-478
11-digit product format 502680478
Labeler code 50268
Product ID 50268-478_47e6f1e5-f12c-c5d1-e063-6294a90a78b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEFLUNOMIDE
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA077090
Marketing category ANDA
Marketing start 2020-09-17
Substance LEFLUNOMIDE
Active strength 20 mg/1
Pharmacologic classes Antirheumatic Agent [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 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 A077090-001 LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 A077090-002 LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13
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 3 · 84 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 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077090-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2005-09-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077090-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2005-09-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LEFLUNOMIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEFLUNOMIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G162GK9U4W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205284 Internal RxNorm lookup 205285 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 50268-478-11 LEFLUNOMIDE 1 in 1 BLISTER PACK TABLET 1 4 50268-478-15 LEFLUNOMIDE 50 in 1 BOX TABLET 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-478 LEFLUNOMIDE TABLET [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20240110_af836cd0-da42-772e-e053-2995a90ac103.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-478-11 50268047811 1 in 1 BLISTER PACK Historical 50268-478-15 50268047815 50 BLISTER PACK in 1 BOX (50268-478-15) / 1 TABLET in 1 BLISTER PACK (50268-478-11) 50 blister pack 2020-09-17 0000-00-00 No No Current