FDA.reportPublic FDA data

NDC 0781-7136-58 - 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
0781-7136
Requested NDC
0781-7136-58
Package NDCs from labels
0781-7136-58, 0781-7136-54
Manufacturer
Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc.
Effective date
2026-03-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc.Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc.2026-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-7136-54Estradiol Transdermal System4 in 1 CARTONPATCH410
0781-7136-58Estradiol Transdermal System7 d in 1 PATCHPATCH710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7136ESTRADIOL TRANSDERMAL SYSTEM (ESTRADIOL) PATCH [SANDOZ INC]7Current NDC, Legacy NDC, 2 package rows20231215_c714974b-766f-42f2-a846-b0c1f5a60560.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7136-54EA - Each0781-713685cabed8-16f1-47c8-9030-94f010b8fd3a12018-10-11
0781-7136-58EA - Each0781-71369f5c92fe-1c0f-4d94-82b5-ae3f1fba760912018-10-11

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 2 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLREMEDYREPACK INC.774ee81b-8e29-46af-ab12-7157f63b443b2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstroGelESTRADIOLASCEND Therapeutics US, LLC762ac371-bb8b-47e7-b48f-e80d452c9dd42026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC50c786d6-91bd-4eea-9455-ff2abc08372f2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutionsafd70875-0a93-40a7-842e-f4359818c2d92026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOL GEL 0.1%Xiromed, LLC1a46efe6-21b9-3f0f-90b9-59f279ef51df2026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLEncube Ethicals, Inc.54f108d6-ddd2-4276-8508-2c8e16a65fb22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol GelESTRADIOLEncube Ethicals, Inc.d4a3606f-83b2-45df-bc77-faebfa796f9a2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstringESTRADIOLPfizer Laboratories Div Pfizer Inc110b9865-5a07-4d45-b560-e89947f126002026-04-23Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLA-S Medication Solutions0137d491-6917-4060-9b32-e0cd7b0badbb2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPreferred Pharmaceuticals, Inc.6d129a94-8ecd-40a3-9a95-c5e1ece41ab12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepack67f581cb-6d77-49fc-b2f3-976e3b57dcbf2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ClimaraESTRADIOLBayer HealthCare Pharmaceuticals Inc.1e9702c4-f2d7-4ea8-b6e8-7dca316718642026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020375
rxcui: 238003
rxcui: 238004
rxcui: 242333
rxcui: 403923
rxcui: 403922
rxcui: 241527
unii: 4TI98Z838E
MenostarESTRADIOLBayer HealthCare Pharmaceuticals Inc.a78708cd-04d4-4221-a4e4-53680bbe29122026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020375
unii: 4TI98Z838E
Estradiol Transdermal SystemESTRADIOLSandoz Incc714974b-766f-42f2-a846-b0c1f5a605602026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020375
ndc (package): 0781-7134-58
ndc (package): 0781-7122-58
ndc (package): 0781-7104-58
ndc (package): 0781-7133-58
ndc (package): 0781-7104-54
ndc (package): 0781-7122-54
ndc (package): 0781-7136-54
ndc (package): 0781-7119-58
ndc (package): 0781-7119-54
ndc (package): 0781-7134-54
ndc (package): 0781-7136-58
ndc (package): 0781-7133-54
ndc (product): 0781-7104
ndc (product): 0781-7133
ndc (product): 0781-7122
ndc (product): 0781-7136
ndc (product): 0781-7134
ndc (product): 0781-7119
ndc11 (package): 00781713658
rxcui: 238003
rxcui: 238004
rxcui: 242333
rxcui: 403923
rxcui: 403922
rxcui: 241527
spl id: 1f2a1b63-ca41-4695-a296-542c1dc04b79
spl set id: c714974b-766f-42f2-a846-b0c1f5a60560
unii: 4TI98Z838E
AngeliqDROSPIRENONE AND ESTRADIOLBayer HealthCare Pharmaceuticals Inc.761834c2-6b61-4583-84c2-f1ca4a97c4f22026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPadagis Israel Pharmaceuticals Ltd3ac905b3-904c-4285-97ed-e787d006c7dd2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DIVIGELESTRADIOLVertical Pharmaceuticals, LLC59e610dc-883e-4f07-9ec6-a5841b0bf9fb2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female StimulantACONITICUM ACIDUM, CIS-, APIS VENENUM PURUM, AQUILEGIA VULGARIS, BOVISTA, CYPRIPEDIUM PUBESCENS, ESTRADIOL, FAECALIS (ALKALIGENES), FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, KREOSOTUM, LACHESIS MUTUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, MUTABILE BACILLUS (BACH), OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PINEAL GLAND (SUIS), PLACENTA TOTALIS SUIS, PROGESTERONE, SEPIA, TESTOSTERONE, UTERUS (SUIS)Deseret Biologicals, Inc.0d4b8cbf-8f57-43ca-a904-c69d9056c8652026-02-19WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOL TRANSDERMALAmneal Pharmaceuticals NY LLC9669a0e3-27e2-4f6c-961c-7a67e9f84cc82026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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