FDA.reportPublic FDA data

NDC 70710-1158-01 - 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
70710-1158
Requested NDC
70710-1158-01
Package NDCs from labels
70710-1158-3, 70710-1158-1, 70710-1158-5, 70710-1158-01
Manufacturer
A-S Medication Solutions
Effective date
2025-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
leflunomide - A-S Medication SolutionsA-S Medication Solutions2025-04-14HUMAN PRESCRIPTION DRUG LABEL
leflunomide - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2025-01-10HUMAN PRESCRIPTION DRUG LABEL
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
leflunomide - Bryant Ranch PrepackBryant Ranch Prepack2024-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1158-1leflunomide100 in 1 BOTTLETABLET, FILM COATED1006
70710-1158-3leflunomide30 in 1 BOTTLETABLET, FILM COATED306
70710-1158-5leflunomide500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1158LEFLUNOMIDE 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
70710-1158-3EA - Each70710-115845edd2bd-36f4-402a-b56b-3c1a94e11a1212019-07-02

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 109 of 130 · 2,588 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8ab49def-c9cd-489e-a936-467067a889402023-12-16WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production0cb8f22d-2343-415e-9f16-1791567864a12023-12-16WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc83725be5-4a0a-4717-a034-ff2999dd40992023-12-16WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME NUDE SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L337a771e-c965-421a-a8e7-d853ffe51c2c2023-12-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 MediumTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Productionb4cef09a-f0e4-4054-a200-667df7d150bf2023-12-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 MediumTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc1f3b56d5-c33a-401f-8c8a-924345a4846e2023-12-15WarningsExact identifier
unii: 15FIX9V2JP
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIsagenix International, LLC6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce2023-12-14WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01TITANIUM DIOXIDEOrveon Global US LLC29738578-6681-476e-8660-7219f58e8fa02023-12-13WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production4e56f3f2-b856-4bbc-ab39-6fb5887a48462023-12-13WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2ce83dc2-84b6-43fd-8b11-495d41cebc222023-12-13WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDECosmetique Active Production4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca2023-12-13WarningsExact identifier
unii: 15FIX9V2JP
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30TITANIUM DIOXIDERodan & Fields1a936053-2be0-4c52-a073-ba846b87f8112023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Broad Spectrum SPF 30 Up The AntiTITANIUM DIOXIDE, ZINC OXIDEBiopelle, Inc.37506766-370e-4ae4-8dbe-915a763e7c552023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Youth Activating BB SPF30 Shade 3ZINC OXIDE, TITANIUM DIOXIDEEnglewood Lab, Inc.c84207c4-a779-4c00-a486-86eaf8ece1692023-12-12WarningsExact identifier
unii: 15FIX9V2JP
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 MinTITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.5742da4b-6713-4de9-8ab8-b2bf2983371a2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Laura Mercier Flawless Skin Daily Face Shield SPF 40OCTINOXATE, TITANIUM DIOXIDEGurwitch Products, LLCf86729cd-682f-47b2-9bfa-1113721bfec02023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Boscia BB SPF 27 PATITANIUM DIOXIDEBoscia LLC5dc86c0b-c340-4643-a174-a6b4c0826ca92023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC82a23aab-404f-46bb-afaa-8ba9b9bdbefd2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5f5fb9f5-00be-420a-b19a-b753c45f9a882023-12-12WarningsExact identifier
unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03TITANIUM DIOXIDE3LAB, Inc.8a42a9d8-b9c6-45fb-8264-15f36e2765f02023-12-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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