Home NDC 0955-1735 Leflunomide
Product NDC 0955-1735
11-digit product format 009551735
Labeler code 0955
Product ID 0955-1735_b2fa424f-afd3-47b7-bf2d-44b9f0e88324
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Winthrop U.S.
Application NDA020905
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-09-07
Marketing end 0000-00-00
Substance LEFLUNOMIDE
Active strength 10 mg/1
Pharmacologic classes Antirheumatic Agent [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 23 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0955-1735-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0955-1735-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0955-1735-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0955-1735-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0955-1735-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0955-1735-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0955-1735-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0955-1735-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0955-1735-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0955-1735-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0955-1735-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0955-1735-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020905-001 ARAVA LEFLUNOMIDE 10MG TABLET / ORAL AB RLD 1998-09-10 N020905-002 ARAVA LEFLUNOMIDE 20MG TABLET / ORAL AB RLD, RS 1998-09-10 N020905-003 ARAVA LEFLUNOMIDE 100MG TABLET / ORAL RLD 1998-09-10
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 4 · 126 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 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020905-003 ARAVA 100MG TABLET / ORAL RLD 1998-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded leflunomide ACTIVE INGREDIENT G162GK9U4W LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 leflunomide ACTIVE MOIETY G162GK9U4W LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 Crospovidone INACTIVE INGREDIENT 68401960MK LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 povidones INACTIVE INGREDIENT FZ989GH94E LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0955-1735 LEFLUNOMIDE TABLET, FILM COATED [WINTHROP U.S.] 13 Legacy NDC 20240723_eb85de02-2964-453b-978a-26451cd1c97a.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arava LEFLUNOMIDE sanofi-aventis U.S. LLC 320f63f2-fac3-4aee-aff8-85724e00ef52 2025-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020905 application number: NDA020905
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0955-1735-30 00955173530 1 BOTTLE in 1 CARTON (0955-1735-30) > 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-09-07 0000-00-00 No No Current