FDA.reportPublic FDA data

NDC 70710-1127-01 - Ursodiol

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
70710-1127
Requested NDC
70710-1127-01
Package NDCs from labels
70710-1127-1, 70710-1127-5, 70710-1127-01
Manufacturer
American Health Packaging
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ursodiol - American Health PackagingAmerican Health Packaging2025-11-13HUMAN PRESCRIPTION DRUG LABEL
Ursodiol - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2024-03-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1127-1Ursodiol100 in 1 BOTTLETABLET1007
70710-1127-5Ursodiol500 in 1 BOTTLETABLET5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1127URSODIOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, Legacy NDC, 2 package rows20240323_55c1556b-8b47-479a-979b-fd61bdd27c7f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1127-1EA - Each70710-1127a19dd504-b31a-4415-8c68-8d7ff8a66d1d12019-01-24

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 104 of 139 · 2,772 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UrsodiolURSODIOLBryant Ranch Prepack46cfd68f-9a6e-4a00-a3e7-11d130b571fe2024-10-03Warnings, Adverse reactionsExact identifier
rxcui: 858751
unii: 724L30Y2QR
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
Bone Support HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPATORIUM PERFOLIATUM, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, STRONTIUM CARBONICUM, SYMPHYTUM OFFICINALEEnergique, Inc.da6937b9-da23-4e78-96af-2ca40f973a022024-09-30WarningsExact identifier
unii: ETJ7Z6XBU4
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
LymphaparECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEAEnergique, Inc.c746c111-7ebc-46c1-b11b-04271887df9c2024-09-23WarningsExact identifier
unii: ETJ7Z6XBU4
HP AxisARGENTUM 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, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: ETJ7Z6XBU4
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
ChronagesicARNICA 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, APIOLUMDeseret Biologicals, Inc.66e351ed-d359-4367-a950-fc57b37489ab2024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCANTIMONIUM 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-49d7-9161-92ef644338832024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
FocusGINKGO 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 NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
MammaryplexECHINACEA (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-8691-26dd577014a82024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: B697894SGQ
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: 15FIX9V2JP
Lymph LiquescenceECHINACEA (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 RANANutritional Specialties, Inc.866ac8e1-431c-4c8b-b052-f6c4cff3769b2024-09-05WarningsExact identifier
unii: ETJ7Z6XBU4
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
unii: 15FIX9V2JP
Geopathic StressALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, SYMPHYTUM OFFICINALE, AGATE, CALCAREA CARBONICA, FERRUM METALLICUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, X-RAY, CUPRUM METALLICUM, TARENTULA HISPANABioActive Nutritional, Inc.7f4a18fc-1188-4201-85d5-f2d4d9d3fb7b2024-08-29WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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