Home NDC 35573-447 Leflunomide
Product NDC 35573-447
11-digit product format 355730447
Labeler code 35573
Product ID 35573-447_81914a50-0e77-480d-aec5-2889b31a66d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA213497
Marketing category ANDA
Marketing start 2022-01-03
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213497-001 LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 A213497-002 LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10
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 2 · 68 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 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2021-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2021-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213497-001 LEFLUNOMIDE 10MG TABLET / ORAL 2021-05-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213497-002 LEFLUNOMIDE 20MG TABLET / ORAL 2021-05-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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 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 · 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 35573-447-30 Leflunomide 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-447 LEFLUNOMIDE TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20250425_fc044417-cd9a-42f6-8a3d-a14e7c2f81a2.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 Marketing start Marketing end Sample Exclude flag Status 35573-447-30 35573044730 30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30) 2022-01-03 0000-00-00 No No Current