FDA.reportPublic FDA data

NDC 59368-421-01 - Estradiol Transdermal System

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
59368-421
Requested NDC
59368-421-01
Package NDCs from labels
59368-421-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol Transdermal System - Praxis, LLCPraxis, LLC2023-01-01HUMAN PRESCRIPTION DRUG LABEL

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 6 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EvamistESTRADIOLPadagis US LLC9a0aa631-133d-406b-9d32-8a1a99af4e502024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3518120e-cc44-4d70-8a20-0ef2dce9a3c62024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstrogensESTRADIOL, FOLLICULINUM, OOPHORINUM (SUIS)Energique, Inc.e0686139-824f-42bc-8610-bb003d7edc3f2024-10-24WarningsExact identifier
unii: 4TI98Z838E
ESTROGEN PHENOLICESTRADIOL,Energique, Inc.716cd86c-af47-45a6-b710-fed421e78fb52024-10-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLProficient Rx LP7e570b07-2a9e-49bf-b224-1e34f6eda3ab2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.230c2eda-b0f1-d9ec-e063-6394a90a603c2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 4TI98Z838E
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack5e9bd73f-67db-44f9-a5ee-409eed765cd22024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Immune ForteDEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)BioActive Nutritional, Inc.9c355245-260a-464b-abcf-95416b49caa32024-08-29WarningsExact identifier
unii: 4TI98Z838E
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack75fc6d3a-49b6-47ad-b704-410692010d3a2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepackb119df4a-c514-4804-b1a8-b09c6058e80d2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepackf419192a-eb95-4087-9fe0-0eea639ef51b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRACEESTRADIOLA-S Medication Solutionsda52a602-f2a2-4382-be07-30351c58cc4b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack779751dc-243a-4dc2-ae67-3669f196b2052024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepacke7b15ec3-e195-44a6-bdd7-9b6de2b235b82024-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.5423c0da-eb10-20cd-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack99b889a0-6200-4727-97d3-f5a0b7814e1b2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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