FDA.reportPublic FDA data

Climara

Product NDC
50419-456
11-digit product format
504190456
Labeler code
50419
Product ID
50419-456_c092f921-73f7-45be-b928-744cfdd24b49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA020375
Marketing category
NDA
Marketing start
2003-05-27
Substance
ESTRADIOL
Active strength
.0375 mg/d
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Climara
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.0375 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui238003, 238004, 241527, 242333, 310170, 310174, 310178, 310181, 403922, 403923, 404656, 404657

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-456-01Climara7 d in 1 PATCHPATCH725
50419-456-04Climara4 in 1 CARTONPATCH425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-456-01EA - Each50419-456c7a15d00-b545-41da-8f6a-298fe4dc76d412020-03-10
50419-456-04EA - Each50419-45605a089c6-f114-48bd-9565-056c46f854fa12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-456CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20241109_1e9702c4-f2d7-4ea8-b6e8-7dca31671864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310170Climara 0.025 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404656Climara 0.0375 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310174Climara 0.05 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404657Climara 0.06 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310178Climara 0.075 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310181Climara 0.1 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
242333estradiol 0.025 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403922estradiol 0.0375 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238003estradiol 0.05 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403923estradiol 0.06 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
241527estradiol 0.075 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238004estradiol 0.1 MG/Day Weekly Transdermal SystemPSN1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310170168 HR estradiol 0.00104 MG/HR Transdermal System [Climara]SBD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404656168 HR estradiol 0.00156 MG/HR Transdermal System [Climara]SBD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310174168 HR estradiol 0.00208 MG/HR Transdermal System [Climara]SBD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404657168 HR estradiol 0.0025 MG/HR Transdermal System [Climara]SBD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310178168 HR estradiol 0.00312 MG/HR Transdermal System [Climara]SBD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310181168 HR estradiol 0.00417 MG/HR Transdermal System [Climara]SBD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
242333168 HR estradiol 0.00104 MG/HR Transdermal SystemSCD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403922168 HR estradiol 0.00156 MG/HR Transdermal SystemSCD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238003168 HR estradiol 0.00208 MG/HR Transdermal SystemSCD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403923168 HR estradiol 0.0025 MG/HR Transdermal SystemSCD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
241527168 HR estradiol 0.00312 MG/HR Transdermal SystemSCD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238004168 HR estradiol 0.00417 MG/HR Transdermal SystemSCD1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310170168 HR Climara 0.00104 MG/HR Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404656168 HR Climara 0.00156 MG/HR Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310174168 HR Climara 0.00208 MG/HR Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404657168 HR Climara 0.0025 MG/HR Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310178168 HR Climara 0.00312 MG/HR Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310181168 HR Climara 0.00417 MG/HR Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310170Climara 0.025 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310170Climara 0.025 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404656Climara 0.0375 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404656Climara 0.0375 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310174Climara 0.05 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310174Climara 0.05 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404657Climara 0.06 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
404657Climara 0.06 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310178Climara 0.075 MG/Day Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310178Climara 0.075 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310181Climara 0.1 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
310181Climara 0.1 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
242333estradiol 0.025 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
242333estradiol 0.025 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403922estradiol 0.0375 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403922estradiol 0.0375 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238003estradiol 0.05 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238003estradiol 0.05 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403923estradiol 0.06 MG/24HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
403923estradiol 0.06 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
241527estradiol 0.075 MG/Day Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
241527estradiol 0.075 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238004estradiol 0.1 MG per 24 HR Weekly Transdermal PatchSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425
238004estradiol 0.1 MG/Day Weekly Transdermal SystemSY1e9702c4-f2d7-4ea8-b6e8-7dca3167186425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-456-01504190456017 d in 1 PATCH7 dHistorical
50419-456-04504190456044 PATCH in 1 CARTON (50419-456-04) / 7 d in 1 PATCH (50419-456-01) 4 patch2003-05-270000-00-00NoNoCurrent