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 7 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLBryant Ranch Prepack9eb88585-4994-474f-bd63-c4e003bf6f202024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack7eb1b2c3-8ece-47c3-96c0-606f7f5b5a322024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepackd9514497-6b9e-4c13-950b-6b036ff101c12024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.1bbdb10b-9a32-3899-e063-6294a90ab26d2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL AND NORETHINDRONE ACETATENaari Pte. Limitedf70185fe-9fcf-655f-e053-6394a90a20dc2024-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNuCare Pharmaceuticals,Inc.7093dbe4-b096-2ddb-e053-2991aa0a1bb82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
MimveyESTRADIOL AND NORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.b1c5c06b-9ce2-4bf7-9693-e37608055a142024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRACEESTRADIOLAllergan, Inc.dfc41fcd-c5ba-4b25-b647-cf04d3988b3e2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLCd4259bb8-91f8-4587-8ceb-35d44145aec02024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
LYLLANAESTRADIOLAmneal Pharmaceuticals LLC09c472c6-a38a-4a3d-b048-6fefd52e2ad32024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLC0500ee9b-bf4a-4432-9afe-20a7d60a6fe52024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLAmneal Pharmaceuticals LLC53016d30-6b5f-49da-ac16-85ef415a58052024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepack0e927450-3f02-4d2f-9235-a255357e8d932024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepack6a4e82a4-d980-4c04-9e33-9444a292728a2024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackeab9a629-b3d4-4faf-bce4-656fe3b46d382024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3fe899db-a8cd-4a31-88fb-1129be96b4d92024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNoven Therapeutics, LLCbf185599-2138-4083-9c52-2b95dce09ae02024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack80d6644a-d6f2-48e7-a685-92c4255b19fe2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack414b846a-d6d9-4e8a-9632-12e296fc13c32024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
YUVAFEMESTRADIOLAmneal Pharmaceuticals LLC30c7f6ba-7a9e-4853-b3e4-e00a465602242024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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