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 4 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.f3a77482-f490-f350-e053-2a95a90ad8cb2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.c8ac2e13-58d5-4e70-e053-2995a90aff042025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionse962e36d-5d84-4b39-9bdf-e5f9a264b82a2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238003
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions13f9c41b-417c-45e4-9a59-baf774fca78d2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.e7e6da3b-8485-1382-61c9-e9b369018b982025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238003
rxcui: 238004
rxcui: 242333
rxcui: 403923
rxcui: 403922
rxcui: 241527
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.f4efb0bf-b96f-4e20-a0f2-0806ab92b2d42025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLCoupler LLC37c99e4d-fb0d-0e6e-e063-6394a90a69c82025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.d28bec8f-762e-4f05-a20d-96a42970d6a72025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC0c8a07a4-5762-eaf4-e063-6394a90a54ff2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen CreamESTRIOL,ESTRADIOLSHYNE BRANDSc4d3860f-c211-b18c-e053-2a95a90a44742025-06-01WarningsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen Cream - 3.6ozESTRIOL,ESTRADIOLSHYNE BRANDS/BIOLabs PRO37d33647-9790-35a8-e063-6294a90a2ad92025-06-01WarningsExact identifier
unii: 4TI98Z838E
3.6oz BiEST 2.5 Estrogen CreamESTRIOL,ESTRADIOL,ESTROGEN CREAMSHYNE BRANDS/BIOLabs PRO37e49c0d-f89f-f88d-e063-6294a90a3f5c2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Balance Plus CreamESTRIOL,ESTRADIOL,PROGESTERONE,DHEASHYNE BRANDS/BIOLabs PRO37e5e4ae-8cb1-19bb-e063-6294a90ac43d2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Estradiol Vaginal CreamESTRADIOLPrasco Laboratoriesc895ac14-5dbd-4201-bf3e-ba7c38a4e9942025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female StimulantLILIUM TIGRINUM, BOVISTA, CYPRIPEDIUM PUBESCENS, HYDRASTIS CANADENSIS, PETROSELINUM SATIVUM, AQUILEGIA VULGARIS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), KREOSOTUM, OOPHORINUM (SUIS), UTERUS (SUIS), FOLLICULINUM, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, SEPIA, PINEAL GLAND (SUIS), HYPOPHYSIS SUIS, ACONITICUM ACIDUM CIS-, APIS VENENUM PURUM, ESTRADIOL, PROGESTERONE, TESTOSTERONE, PLACENTA TOTALIS SUIS, FAECALIS (ALKALIGENES), MUTABILE BACILLUS (BACH)Deseret Biologicals, Inc.18d072ec-93e1-4e20-82db-98e80b81c3632025-05-27WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmerican Health Packaging265a1ee1-f314-4324-a2e1-0120a9a00a202025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.9956a196-fefd-4766-a225-e154fbd3aeff2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions3e84e3e7-4b50-407f-a215-45363b5413842025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPreferred Pharmaceuticals Inc.72fbd5a8-9c34-4790-84ed-79f5bd3ae0f02025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Prostate LiquescenceSABAL SERRULATA, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ESTRADIOL, PROGESTERONE, CONIUM MACULATUM ASTERIAS RUBENS, EUPHORBIUM OFFICINARUM, TRITICUM REPENS, CALCAREA FLUORICA, ARSENICUM ALBUMNutritional Specialties, Inc.0cb4729c-63cd-463b-b1c4-df85118986d02025-04-07WarningsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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