Home NDC 0088-2160 Arava
Product NDC 0088-2160
11-digit product format 000882160
Labeler code 0088
Product ID 0088-2160_765327c7-cb5b-4637-84da-4fd9a024ad96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler sanofi-aventis U.S. LLC
Application NDA020905
Marketing category NDA
Marketing start 1998-09-10
Substance LEFLUNOMIDE
Active strength 10 mg/1
Pharmacologic classes Antirheumatic Agent [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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Arava
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEFLUNOMIDE 10 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205284 Internal RxNorm lookup 205285 Internal RxNorm lookup 205286 Internal RxNorm lookup 213377 Internal RxNorm lookup 213379 Internal RxNorm lookup 213380 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 0088-2160-30 Arava 30 in 1 BOTTLE TABLET, FILM COATED 30 27 0088-2160-30 Arava 1 in 1 CARTON TABLET, FILM COATED 1 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded leflunomide ACTIVE INGREDIENT G162GK9U4W ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 leflunomide ACTIVE MOIETY G162GK9U4W ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 crospovidone INACTIVE INGREDIENT 68401960MK ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 povidones INACTIVE INGREDIENT FZ989GH94E ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 talc INACTIVE INGREDIENT 7SEV7J4R1U ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0088-2160 ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 26 Current NDC, Legacy NDC, 2 package rows 20241109_320f63f2-fac3-4aee-aff8-85724e00ef52.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 ndc (product): 0088-2160
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 0088-2160-30 00088216030 1 BOTTLE in 1 CARTON (0088-2160-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1998-09-19 0000-00-00 No No Current