FDA.reportPublic FDA data

NDC 70710-1157-01 - leflunomide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70710-1157
Requested NDC
70710-1157-01
Package NDCs from labels
70710-1157-3, 70710-1157-1, 70710-1157-5, 70710-1157-01
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited
Effective date
2024-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
leflunomide - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2024-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1157-1leflunomide100 in 1 BOTTLETABLET, FILM COATED1006
70710-1157-3leflunomide30 in 1 BOTTLETABLET, FILM COATED306
70710-1157-5leflunomide500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1157LEFLUNOMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6Current NDC, Legacy NDC, 3 package rows20240815_b9af9870-014f-4c4e-8738-bb04b30b3e85.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1157-3EA - Each70710-11576f11bc04-56c1-448d-82f9-b762a399c33e12019-07-02

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 61 of 132 · 2,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Dizziness HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM,Energique, Inc.0bf53ecc-c2ad-40b5-b921-7c10a1b006262025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5eb1c-b268-acfb-e063-6394a90ad4cc2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6157a-4b62-8279-e063-6294a90abe052025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6252f-56b8-9e3c-e063-6294a90aa12c2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c62e80-9ace-c1f2-e063-6294a90a5bfa2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6864c-bc8e-e900-e063-6294a90a7a142025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c77b48-18fb-3efe-e063-6294a90ade4b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c784ce-3a54-5416-e063-6294a90ac9a22025-11-17WarningsExact identifier
unii: 15FIX9V2JP
Daily Essential Eye CreamTITANIUM DIOXIDE, ZINC OXIDESolarium Brands LLC2a931d9f-4ba8-e3a5-e063-6294a90af7802025-11-17WarningsExact identifier
unii: 15FIX9V2JP
Hell on Earth The Resistance Daily Face MoisturizerTITANIUM DIOXIDE, ZINC OXIDEHell on Earth38debebf-1e12-09f3-e063-6294a90a9a2a2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
Woro Beauty SPFortlessTITANIUM DIOXIDE, ZINC OXIDEWoro Beauty3d86ef02-c947-2791-e063-6394a90a42cc2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
Formica Stibium comp.FORMICA STIBIUM COMP.Uriel Pharmacy Inc.439073f2-1dee-4b4e-a65e-74aee1c73c2b2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.