FDA.reportPublic FDA data

NDC 50419-459-01 - Climara

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
50419-459
Requested NDC
50419-459-01
Package NDCs from labels
50419-459-01, 50419-459-04
Manufacturer
Bayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Climara - Bayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLCBayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC2026-03-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-459-01Climara7 d in 1 PATCHPATCH725
50419-459-04Climara4 in 1 CARTONPATCH425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-459CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20241109_1e9702c4-f2d7-4ea8-b6e8-7dca31671864.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-459-01EA - Each50419-4591811de30-c4c0-49d2-9ba5-3bb39cf1246512020-03-10
50419-459-04EA - Each50419-4590ab42d15-6da5-46a5-a388-15e3cb4c726812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838ECLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
ESTRADIOLACTIVE MOIETY4TI98Z838ECLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]8

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 1 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estriora CreamESTRIOL AND ESTRADIOL CREAMGuangzhou Shunfei Network Technology Co., Ltd.5a53c026-aa7c-6c09-e063-6394a90a36e12026-08-31WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsc8a2d29c-299c-4559-b859-87b303a4af812026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
GynobalanceDEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.61fa6e6e-42f5-4992-87b5-0770218abc8c2026-08-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTrigen Laboratories, LLCe84ad638-6768-41aa-b2b8-e2514ef638812026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
MinivelleESTRADIOLNoven Therapeutics, LLC6c5c47ab-28ee-11e1-bfc2-0800200c9a662026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutions1521007a-546d-421e-99e1-e10d90c0b0902026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.ff28c624-906d-459c-8b8c-27cb1a664e122026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepacke6bf2abc-71ae-4e79-a37b-164c98ba746a2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 241527
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.59a4b68d-a507-4809-a0c8-fd9799986d122026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsba935918-39b3-4b56-bd83-78a29958e6d82026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403922
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions1c38f0d0-a360-4b66-bc0e-7d54e92465a12026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403923
unii: 4TI98Z838E
ESTRADIOLESTRADIOLREMEDYREPACK INC.477cb52e-8ce2-491f-94a0-869ff60bf7ab2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionseacafc4a-2fa8-403d-8df7-2bc92d73a54f2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238004
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsee5460ab-27e7-487a-a89c-bf8735399be62026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242333
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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