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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021258-001CLIMARA PROESTRADIOL; LEVONORGESTREL0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4TI98Z838EInternal UNII lookup
5W7SIA7YZWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402250Internal RxNorm lookup
402252Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
184d3092-7fc6-4375-816b-1ab06bb99cfdAvailable on FDA.report

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#

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

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021258
application number: NDA021258
ndc (product): 50419-491

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