Estradiol

Product NDC
50090-7984
Requested package NDC
50090-7984-0
11-digit product format
500907984
Labeler code
50090
Product ID
50090-7984_b6dfdda4-bb82-4105-81ed-3ce36bce881b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
A-S Medication Solutions
Application
ANDA075182
Marketing category
ANDA
Marketing start
2000-03-01
Substance
ESTRADIOL
Active strength
.1 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075182-001ESTRADIOLESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24
A075182-002ESTRADIOLESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26
A075182-003ESTRADIOLESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26
A075182-004ESTRADIOLESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20
A075182-005ESTRADIOLESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20
A075182-006ESTRADIOLESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075182-001AB2
A075182-002AB2
A075182-003AB2
A075182-004AB2
A075182-005AB2
A075182-006AB2

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-2484e616aacf4f…
2026-09-14 22:38:342026-08A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-2684e616aacf4f…
2026-09-14 22:38:342026-08A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-2684e616aacf4f…
2026-09-14 22:38:342026-08A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-2084e616aacf4f…
2026-09-14 22:38:342026-08A075182-005ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-2084e616aacf4f…
2026-09-14 22:38:342026-08A075182-006ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-2484e616aacf4f…
2026-08-18 06:07:402026-07A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-005ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-006ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-005ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-006ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-005ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-006ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-005ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-006ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-005ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-006ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-001ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22000-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-002ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-003ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22005-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-004ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22006-07-20b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075182-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A075182-002AB2184e616aacf4f…
2026-09-14 22:38:342026-08A075182-003AB2184e616aacf4f…
2026-09-14 22:38:342026-08A075182-004AB2184e616aacf4f…
2026-09-14 22:38:342026-08A075182-005AB2184e616aacf4f…
2026-09-14 22:38:342026-08A075182-006AB2184e616aacf4f…
2026-08-18 06:07:402026-07A075182-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-002AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-003AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-004AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-005AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A075182-006AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075182-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-004AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-005AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075182-006AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-004AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-005AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075182-006AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075182-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-004AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-005AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075182-006AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-004AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-005AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075182-006AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075182-004AB21b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.1 mg/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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238004Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eacafc4a-2fa8-403d-8df7-2bc92d73a54fAvailable on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182
EstradiolESTRADIOLA-S Medication Solutionsba935918-39b3-4b56-bd83-78a29958e6d82026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182
EstradiolESTRADIOLA-S Medication Solutions1c38f0d0-a360-4b66-bc0e-7d54e92465a12026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182
EstradiolESTRADIOLA-S Medication Solutionseacafc4a-2fa8-403d-8df7-2bc92d73a54f2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182
ndc (package): 50090-7984-0
ndc (product): 50090-7984
ndc11 (package): 50090798400
EstradiolESTRADIOLA-S Medication Solutionsee5460ab-27e7-487a-a89c-bf8735399be62026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182
EstradiolESTRADIOLA-S Medication Solutionse962e36d-5d84-4b39-9bdf-e5f9a264b82a2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182
EstradiolESTRADIOLMylan Pharmaceuticals Inc.e7e6da3b-8485-1382-61c9-e9b369018b982025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075182
application number: ANDA075182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7984-0500907984004 POUCH in 1 CARTON (50090-7984-0) / 1 d in 1 POUCH4 pouch2026-06-01NoNoCurrent