Menostar

Product NDC
50419-455
11-digit product format
504190455
Labeler code
50419
Product ID
50419-455_2ace4c5d-880e-4ac1-a5e9-ff8028afc282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA020375
Marketing category
NDA
Marketing start
2004-06-08
Substance
ESTRADIOL
Active strength
14 ug/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

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020375-001CLIMARAESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-22
N020375-002CLIMARAESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-22
N020375-003CLIMARAESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-23
N020375-004CLIMARAESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-05
N020375-005CLIMARAESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27
N020375-006CLIMARAESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N020375-001AB2
N020375-002AB2
N020375-003AB2
N020375-004AB2
N020375-005AB2
N020375-006AB2

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-005CLIMARA0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-006CLIMARA0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-005CLIMARA0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-006CLIMARA0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-005CLIMARA0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-006CLIMARA0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-005CLIMARA0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-006CLIMARA0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-005CLIMARA0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-006CLIMARA0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-005CLIMARA0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-006CLIMARA0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD2003-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-001CLIMARA0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1994-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-002CLIMARA0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD, RS1994-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-003CLIMARA0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1998-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-004CLIMARA0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RLD1999-03-052680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020375-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-004AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-005AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020375-006AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-004AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-005AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020375-006AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020375-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-004AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-005AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020375-006AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-004AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-005AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020375-006AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-004AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-005AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020375-006AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-004AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-005AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020375-006AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-003AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020375-004AB212680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL14 ug/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476545Internal RxNorm lookup
545276Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a78708cd-04d4-4221-a4e4-53680bbe2912Available 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
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
50419-455-04Menostar4 in 1 CARTONPATCH420
50419-455-04Menostar7 d in 1 PATCHPATCH720

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-455-04EA - Each50419-455bc6388e7-3aca-4a34-bb78-3b2669451cf912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EMENOSTAR (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
ESTRADIOLACTIVE MOIETY4TI98Z838EMENOSTAR (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-455MENOSTAR (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 2 package rows20241215_a78708cd-04d4-4221-a4e4-53680bbe2912.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClimaraESTRADIOLBayer HealthCare Pharmaceuticals Inc.1e9702c4-f2d7-4ea8-b6e8-7dca316718642026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020375
application number: NDA020375
MenostarESTRADIOLBayer HealthCare Pharmaceuticals Inc.a78708cd-04d4-4221-a4e4-53680bbe29122026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020375
application number: NDA020375
ndc (product): 50419-455
Estradiol Transdermal SystemESTRADIOLSandoz Incc714974b-766f-42f2-a846-b0c1f5a605602026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020375
application number: NDA020375

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476545estradiol 14 MCG/Day Weekly Transdermal SystemPSNa78708cd-04d4-4221-a4e4-53680bbe291220
545276menostar 14 MCG/Day Weekly Transdermal SystemPSNa78708cd-04d4-4221-a4e4-53680bbe291220
545276168 HR estradiol 0.000583 MG/HR Transdermal System [Menostar]SBDa78708cd-04d4-4221-a4e4-53680bbe291220
476545168 HR estradiol 0.000583 MG/HR Transdermal SystemSCDa78708cd-04d4-4221-a4e4-53680bbe291220
545276168 HR Menostar 0.000583 MG/HR Transdermal SystemSYa78708cd-04d4-4221-a4e4-53680bbe291220
476545estradiol 0.000583 MG/HR Weekly Transdermal PatchSYa78708cd-04d4-4221-a4e4-53680bbe291220
476545estradiol 14 MCG/Day Weekly Transdermal PatchSYa78708cd-04d4-4221-a4e4-53680bbe291220
476545estradiol 14 MCG/Day Weekly Transdermal SystemSYa78708cd-04d4-4221-a4e4-53680bbe291220
545276Menostar 0.014 MG/24HR Weekly Transdermal PatchSYa78708cd-04d4-4221-a4e4-53680bbe291220
545276Menostar 14 MCG per 24 HR Weekly Transdermal PatchSYa78708cd-04d4-4221-a4e4-53680bbe291220
545276menostar 14 MCG/Day Weekly Transdermal SystemSYa78708cd-04d4-4221-a4e4-53680bbe291220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-455-04504190455044 PATCH in 1 CARTON (50419-455-04) / 7 d in 1 PATCH4 patch2004-06-080000-00-00NoNoCurrent