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 3 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLMylan Pharmaceuticals Inc.98770987-b313-4f2a-9aac-db0ab2068cc62026-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLSolaris Pharma Corporation67e8665c-5331-423c-99fd-546ab6cccb072026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
YuvafemESTRADIOLAvKAREd20abc9a-8f47-e274-c9b1-b71c9489761f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLAvKAREbb7b442d-b8c3-b7f0-e053-2a95a90a2c942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol 1557ESTRADIOLProfessional Complementary Health Formulasf0da282a-6c7e-4a18-870f-d0d8efc2c7e92026-01-08WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLDirect_Rx47e446f8-ac16-ea6b-e063-6394a90a17262026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLC106b92da-334c-542f-e063-6394a90aa65b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLC0a1e744c-7926-0e0c-e063-6294a90a80d02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLCf6caf47a-1917-c493-e053-6394a90af63e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLCf6cb38ab-fdff-9c07-e053-6294a90ad59a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNorthwind Health Company, LLCf76aff99-f415-9045-e053-6294a90afd512026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstroPRO Homeopathic OrganotherapyAGNUS CASTUS, ANGELICA SIN, APIS MEL, CIMICIFUGA RAC, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM, GLYCYRRHIZA, OOPHORINUM, PROGESTERONE, SEPIAProBlen4696d365-7667-c25e-e063-6294a90a8dea2025-12-22WarningsExact identifier
unii: 4TI98Z838E
High Vitality TabAGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), PROTEUS (MORGANI)Deseret Biologicalsd13cfd09-8f8d-4b39-b60e-0e7886af2a562025-12-11WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c94738ff-dece-4fb6-bb44-4f8832a45f382025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Histamine BalancerALLIUM CEPA, GALPHIMIA GLAUCA, SABADILLA, APIS MELLIFICA, ESTRADIOL, KALI SULPHURICUM, GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), STOMACH (SUIS), HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), AMBROSIA ARTEMISIAEFOLIA, CARBO VEGETABILIS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG,Nutritional Specialties, Inc.109b48f9-3588-49f0-ba02-397e09a477d12025-11-19WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC1c2cd11a-e010-20b2-e063-6294a90a52d52025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLPadagis Israel Pharmaceuticals Ltdf76232ed-b109-43d1-bf2e-d41b6420c37d2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepackff3bcb07-f6fe-4582-948a-21dbf1e55f552025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL VAGINAL INSERTSESTRADIOLGlenmark Pharmaceuticals Inc., USA86620f6c-fd02-40df-98d5-3048dcd92c372025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepackf3806b5d-ebd6-43b4-adfa-a1fe86d806422025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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