FDA.reportPublic FDA data

NDC 50419-451-01 - 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
50419-451
Requested NDC
50419-451-01
Package NDCs from labels
50419-451-01, 50419-451-04
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
50419-451-01Climara7 d in 1 PATCHPATCH725
50419-451-04Climara4 in 1 CARTONPATCH425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-451CLIMARA (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
50419-451-01EA - Each50419-45186a8fe65-1afc-48ac-be70-8093d9e46ac112015-08-04
50419-451-04EA - Each50419-4515ea8eafa-59f2-47d4-94dd-f742080769e312012-07-24

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 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
ndc (package): 50419-451-04
ndc (package): 50419-454-04
ndc (package): 50419-453-04
ndc (package): 50419-456-01
ndc (package): 50419-456-04
ndc (package): 50419-454-01
ndc (package): 50419-459-01
ndc (package): 50419-459-04
ndc (package): 50419-452-01
ndc (package): 50419-452-04
ndc (package): 50419-453-01
ndc (package): 50419-451-01
ndc (product): 50419-456
ndc (product): 50419-452
ndc (product): 50419-454
ndc (product): 50419-459
ndc (product): 50419-453
ndc (product): 50419-451
ndc11 (package): 50419045101
rxcui: 404657
rxcui: 310181
rxcui: 310178
rxcui: 238003
rxcui: 238004
rxcui: 310170
rxcui: 242333
rxcui: 404656
rxcui: 403923
rxcui: 403922
rxcui: 241527
rxcui: 310174
spl id: c092f921-73f7-45be-b928-744cfdd24b49
spl set id: 1e9702c4-f2d7-4ea8-b6e8-7dca31671864
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
rxcui: 238003
rxcui: 238004
rxcui: 242333
rxcui: 403923
rxcui: 403922
rxcui: 241527
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.