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 | Type |
|---|---|---|---|
| leflunomide - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited | 2024-08-12 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1157-1 | leflunomide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 6 | |
| 70710-1157-3 | leflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 6 | |
| 70710-1157-5 | leflunomide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1157 | LEFLUNOMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240815_b9af9870-014f-4c4e-8738-bb04b30b3e85.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70710-1157-3 | EA - Each | 70710-1157 | 6f11bc04-56c1-448d-82f9-b762a399c33e | 1 | 2019-07-02 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HP Axis | ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE | Deseret Biologicals, Inc. | 402f5b05-c71e-4dba-bc2b-049aee42952a | 2024-09-23 | Warnings | ETJ7Z6XBU4 |
| Chronagesic | ARNICA MONTANA, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, SANGUINARIA CANADENSIS, SULPHUR, PIPER NIGRUM, ALPHA-LIPOICUM ACIDUM, CARTILAGO SUIS, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS, APIOLUM | Deseret Biologicals, Inc. | 66e351ed-d359-4367-a950-fc57b37489ab | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| VACC HC | ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LAC FELINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM. | Deseret Biologicals, Inc. | a7536e3d-2cdb-49d7-9161-92ef64433883 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Focus | GINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGER | Deseret Biologicals, Inc. | e77857b8-be67-4041-8c8d-9772f17c6d06 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Mammaryplex | ECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE) | BioActive Nutritional, Inc. | 9c9ed6f6-8690-4fbd-8691-26dd577014a8 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Proceuticals Private Label by TiZO tinted mineral sunscreen stick | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 2179a2ff-9425-5b2c-e063-6294a90a45b6 | 2024-09-06 | Warnings | 15FIX9V2JP |
| Leflunomide | LEFLUNOMIDE | Bryant Ranch Prepack | acf3efe4-0d70-4718-9c50-789d69ab215d | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 205285 G162GK9U4W |
| Lymph Liquescence | ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ARSENICUM IODATUM, CURCUMA LONGA, SPLEEN (BOVINE), THYMUS (OVINE), CONIUM MACULATUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, SILICEA, ASTERIAS RUBENS, HYDRASTIS CANADENSIS, BUFO RANA | Nutritional Specialties, Inc. | 866ac8e1-431c-4c8b-b052-f6c4cff3769b | 2024-09-05 | Warnings | ETJ7Z6XBU4 |
| EltaMD UV Physical Rosy Tint SPF40 | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 6bc4d2d4-ef62-4ec0-b514-17257603bac2 | 2024-09-05 | Warnings | 15FIX9V2JP |
| Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 20e86260-d641-c9ac-e063-6394a90ac07d | 2024-08-30 | Warnings | 15FIX9V2JP |
| Freaks of Nature Peak Performance SPF50 | FREAKS OF NATURE PEAK PERFORMANCE SPF50 | Milbar Laboratories | 20b18cea-95e9-3527-e063-6294a90a4db4 | 2024-08-30 | Warnings | 15FIX9V2JP |
| Geopathic Stress | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, SYMPHYTUM OFFICINALE, AGATE, CALCAREA CARBONICA, FERRUM METALLICUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, X-RAY, CUPRUM METALLICUM, TARENTULA HISPANA | BioActive Nutritional, Inc. | 7f4a18fc-1188-4201-85d5-f2d4d9d3fb7b | 2024-08-29 | Warnings | ETJ7Z6XBU4 |
| ASP | ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1) | BioActive Nutritional, Inc. | 66fe5457-fe15-4e33-b47e-2c0dc9b171f6 | 2024-08-28 | Warnings | ETJ7Z6XBU4 |
| Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30 | TITANIUM DIOXIDE AND ZINC OXIDE | Dermio Dermatology LLC | 204973ce-dba4-8235-e063-6394a90a015c | 2024-08-22 | Warnings | 15FIX9V2JP |
| Leflunomide | LEFLUNOMIDE | Alembic Pharmaceuticals Inc. | c288d1d3-3fbe-4c34-a28a-923d515809b3 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 205285 205284 G162GK9U4W |
| MACKENZIES OCEAN SAFE SUNSCREEN | TITANIUM DIOXIDE | Naturally Uncommon, LLC | 1fd0a790-c66c-216f-e063-6294a90ae971 | 2024-08-16 | Warnings | 15FIX9V2JP |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f9df74a8-f225-44ca-91ba-dca4f3f35da0 | 2024-08-13 | Warnings | ETJ7Z6XBU4 |
| leflunomide | LEFLUNOMIDE | Bryant Ranch Prepack | af4079af-c127-476e-a2b3-53b438dc9da4 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ANDA212308 205285 G162GK9U4W |
| leflunomide | LEFLUNOMIDE | Zydus Pharmaceuticals (USA) Inc. | b9af9870-014f-4c4e-8738-bb04b30b3e85 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ANDA212308 70710-1158-5 70710-1158-3 70710-1157-3 70710-1157-5 70710-1158-1 70710-1157-1 70710-1158 70710-1157 70710115701 205285 205284 bd138e7f-33f1-44a4-886b-62f5bfbdfe09 b9af9870-014f-4c4e-8738-bb04b30b3e85 G162GK9U4W |
| leflunomide | LEFLUNOMIDE | Zydus Lifesciences Limited | c66cacd1-93f7-483a-a2fc-aad53d5342b0 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | ANDA212308 205285 205284 G162GK9U4W |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.