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 60 of 132 · 2,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CC Cream Broad Spectrum SPF 30 Merle NormanHOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc93ebe819-6763-400c-8320-812276168b6c2025-11-20WarningsExact identifier
unii: 15FIX9V2JP
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
unii: 15FIX9V2JP
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc3c4b7789-cd73-418e-94cb-834a06cb94082025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incc29cef40-065d-1f8d-e053-2995a90a43e72025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc0a506f55-ea6c-44d3-bab2-0a5875c437572025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inccd4da670-ad26-445e-a243-1e88b54d33352025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc6a6b8780-a11a-4602-aab4-1925d64f786e2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc748a9d28-8814-4394-ad7d-0d6ba868b0bc2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Lasting Foundation SPF 12 Merle NormanTITANIUM DIOXIDEMerle Norman Cosmetics, Incd31cfc74-7dcf-4af1-ba53-63fcad4144642025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Inc.5590d577-3a98-49b8-bb12-ddd7f5cfd0802025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.e12f5324-ed27-4a2e-bf49-f39f7fe351cb2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.3a30b330-7f5f-4a8e-b8bc-1cfaad72f9852025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 L10 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.c892e067-5a79-4903-a1f8-d5a9962c1d5c2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.0ad4ec84-7c82-4ab3-9070-a0764af123062025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF15 L20 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.4a08acf3-41e9-4021-9f4b-99a1fd86b2ec2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incdeaa0035-d030-4831-b2be-8b8bba5d8f552025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.02a4e8f6-f257-4d30-8782-64b4d1622d462025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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