Home NDC 70710-1158 leflunomide
Product NDC 70710-1158
11-digit product format 707101158
Labeler code 70710
Product ID 70710-1158_bd138e7f-33f1-44a4-886b-62f5bfbdfe09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA212308
Marketing category ANDA
Marketing start 2019-04-26
Substance LEFLUNOMIDE
Active strength 20 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 A212308-001 LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 A212308-002 LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24
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 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212308-001 LEFLUNOMIDE 10MG TABLET / ORAL AB 2019-04-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212308-002 LEFLUNOMIDE 20MG TABLET / ORAL AB 2019-04-24 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 2026-12-31 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 70710-1158-1 leflunomide 100 in 1 BOTTLE TABLET, FILM COATED 100 6 70710-1158-3 leflunomide 30 in 1 BOTTLE TABLET, FILM COATED 30 6 70710-1158-5 leflunomide 500 in 1 BOTTLE TABLET, FILM COATED 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1158 LEFLUNOMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 6 Current NDC, Legacy NDC, 3 package rows 20240815_b9af9870-014f-4c4e-8738-bb04b30b3e85.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join leflunomide LEFLUNOMIDE A-S Medication Solutions d6f5c510-9ec2-4e2d-b134-25c35bd23fee 2025-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212308 application number: ANDA212308 leflunomide LEFLUNOMIDE NuCare Pharmaceuticals, Inc. 2b5f387e-b52b-ad80-e063-6394a90a56d5 2025-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212308 application number: ANDA212308 leflunomide LEFLUNOMIDE Bryant Ranch Prepack af4079af-c127-476e-a2b3-53b438dc9da4 2024-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212308 application number: ANDA212308 leflunomide LEFLUNOMIDE Zydus Pharmaceuticals (USA) Inc. b9af9870-014f-4c4e-8738-bb04b30b3e85 2024-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212308 application number: ANDA212308 ndc (product): 70710-1158 leflunomide LEFLUNOMIDE Zydus Lifesciences Limited c66cacd1-93f7-483a-a2fc-aad53d5342b0 2024-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212308 application number: ANDA212308
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 70710-1158-1 70710115801 100 TABLET, FILM COATED in 1 BOTTLE (70710-1158-1) 2019-04-26 0000-00-00 No No Current 70710-1158-3 70710115803 30 TABLET, FILM COATED in 1 BOTTLE (70710-1158-3) 2019-04-26 0000-00-00 No No Current 70710-1158-5 70710115805 500 TABLET, FILM COATED in 1 BOTTLE (70710-1158-5) 2019-04-26 0000-00-00 No No Current