FDA.reportPublic FDA data

Climara Pro

Product NDC
50419-491
11-digit product format
504190491
Labeler code
50419
Product ID
50419-491_9f4e7765-d4e7-4f36-9530-8b4444587214
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol and Levonorgestrel
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA021258
Marketing category
NDA
Marketing start
2003-11-21
Substance
ESTRADIOL; LEVONORGESTREL
Active strength
.045; .015 mg/d; mg/d
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [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 Pro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.045 mg/d
LEVONORGESTREL.015 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E, 5W7SIA7YZW
Rxcui402250, 402252

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
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5a9b579b-8431-5b3a-2ba4-86556704f873Product 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
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-491-04Climara Pro7 d in 1 PATCHPATCH727
50419-491-04Climara Pro4 in 1 CARTONPATCH427
50419-491-73Climara Pro7 d in 1 PATCHPATCH727
50419-491-73Climara Pro1 in 1 CARTONPATCH127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-491-04EA - Each50419-491c130464b-016b-40c7-8a63-69cebbb5ee5a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838ECLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWCLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ESTRADIOLACTIVE MOIETY4TI98Z838ECLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWCLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ESTRADIOLACTIVE INGREDIENT4TI98Z838ECLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [PHYSICIANS TOTAL CARE, INC.]1
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWCLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [PHYSICIANS TOTAL CARE, INC.]1
ESTRADIOLACTIVE MOIETY4TI98Z838ECLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [PHYSICIANS TOTAL CARE, INC.]1
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWCLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-491CLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 4 package rows20241115_184d3092-7fc6-4375-816b-1ab06bb99cfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402252Climara Pro 0.045/0.015 MG/Day Weekly Transdermal SystemPSN184d3092-7fc6-4375-816b-1ab06bb99cfd27
402250estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal SystemPSN184d3092-7fc6-4375-816b-1ab06bb99cfd27
402252168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System [Climara Pro]SBD184d3092-7fc6-4375-816b-1ab06bb99cfd27
402250168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal SystemSCD184d3092-7fc6-4375-816b-1ab06bb99cfd27
402252Climara Pro (estradiol 0.045 MG / levonorgestrel 0.015 MG) per 24HR Weekly Transdermal PatchSY184d3092-7fc6-4375-816b-1ab06bb99cfd27
402252Climara Pro 0.045/0.015 MG/Day Weekly Transdermal SystemSY184d3092-7fc6-4375-816b-1ab06bb99cfd27
402250estradiol 0.00188 MG / levonorgestrel 0.000625 MG/HR Weekly Transdermal PatchSY184d3092-7fc6-4375-816b-1ab06bb99cfd27
402250estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal SystemSY184d3092-7fc6-4375-816b-1ab06bb99cfd27
402250estradiol 45 MCG / levonorgestrel 15 MCG/Day Weekly Transdermal PatchSY184d3092-7fc6-4375-816b-1ab06bb99cfd27
402252Climara Pro 0.045/0.015 MG/Day Weekly Transdermal SystemPSNeabc0fb3-da2a-482f-83a7-99b1e823a1501
402250estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal SystemPSNeabc0fb3-da2a-482f-83a7-99b1e823a1501
402252168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System [Climara Pro]SBDeabc0fb3-da2a-482f-83a7-99b1e823a1501
402250168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal SystemSCDeabc0fb3-da2a-482f-83a7-99b1e823a1501
402252Climara Pro (estradiol 0.045 MG / levonorgestrel 0.015 MG) per 24HR Weekly Transdermal PatchSYeabc0fb3-da2a-482f-83a7-99b1e823a1501
402252Climara Pro 0.045/0.015 MG/Day Weekly Transdermal SystemSYeabc0fb3-da2a-482f-83a7-99b1e823a1501
402250estradiol 0.00188 MG / levonorgestrel 0.000625 MG/HR Weekly Transdermal PatchSYeabc0fb3-da2a-482f-83a7-99b1e823a1501
402250estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal SystemSYeabc0fb3-da2a-482f-83a7-99b1e823a1501
402250estradiol 45 MCG / levonorgestrel 15 MCG/Day Weekly Transdermal PatchSYeabc0fb3-da2a-482f-83a7-99b1e823a1501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-491-04504190491044 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCH4 patch2013-11-210000-00-00NoNoCurrent
50419-491-73504190491731 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCH1 patch2017-04-120000-00-00NoNoCurrent