estradiol

Product NDC
68382-327
Requested package NDC
68382-327-04
11-digit product format
683820327
Labeler code
68382
Product ID
68382-327_bc6ecc76-9efc-435a-ac21-b526a971c343
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA202985
Marketing category
ANDA
Marketing start
2023-11-02
Substance
ESTRADIOL
Active strength
.06 mg/d
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A202985-001ESTRADIOLESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29
A202985-002ESTRADIOLESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29
A202985-003ESTRADIOLESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29
A202985-004ESTRADIOLESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29
A202985-005ESTRADIOLESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29
A202985-006ESTRADIOLESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202985-001AB2
A202985-002AB2
A202985-003AB2
A202985-004AB2
A202985-005AB2
A202985-006AB2

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 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A202985-005ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A202985-006ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2984e616aacf4f…
2026-08-18 06:07:402026-07A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-005ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-006ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-005ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-006ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-005ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-006ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-005ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-006ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-005ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-006ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-004ESTRADIOL0.06MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB22023-03-29b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202985-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A202985-002AB2184e616aacf4f…
2026-09-14 22:38:342026-08A202985-003AB2184e616aacf4f…
2026-09-14 22:38:342026-08A202985-004AB2184e616aacf4f…
2026-09-14 22:38:342026-08A202985-005AB2184e616aacf4f…
2026-09-14 22:38:342026-08A202985-006AB2184e616aacf4f…
2026-08-18 06:07:402026-07A202985-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-002AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-003AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-004AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-005AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A202985-006AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202985-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-004AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-005AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202985-006AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-004AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-005AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202985-006AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202985-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-004AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-005AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202985-006AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-004AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-005AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202985-006AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202985-004AB21b8a1b40f171c…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.06 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238003Internal RxNorm lookup
238004Internal RxNorm lookup
241527Internal RxNorm lookup
242333Internal RxNorm lookup
403922Internal RxNorm lookup
403923Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db4696da-7820-4b2b-97b4-fb05b1208020Available 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
68382-327-01estradiol7 d in 1 PATCHPATCH73
68382-327-01estradiol1 in 1 POUCHPATCH13
68382-327-04estradiol4 in 1 CARTONPATCH43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-327ESTRADIOL PATCH [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, 3 package rows20240322_db4696da-7820-4b2b-97b4-fb05b1208020.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.db4696da-7820-4b2b-97b4-fb05b12080202024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202985
application number: ANDA202985
ndc (package): 68382-327-04
ndc (product): 68382-327
ndc11 (package): 68382032704
estradiolESTRADIOLZydus Lifesciences Limited8b672c79-0896-4d6e-b225-299e89068ad72023-04-21Exact identifier
application applno (ANDA): 202985
application number: ANDA202985

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242333estradiol 0.025 MG/Day Weekly Transdermal SystemPSNdb4696da-7820-4b2b-97b4-fb05b12080203
403922estradiol 0.0375 MG/Day Weekly Transdermal SystemPSNdb4696da-7820-4b2b-97b4-fb05b12080203
238003estradiol 0.05 MG/Day Weekly Transdermal SystemPSNdb4696da-7820-4b2b-97b4-fb05b12080203
403923estradiol 0.06 MG/Day Weekly Transdermal SystemPSNdb4696da-7820-4b2b-97b4-fb05b12080203
241527estradiol 0.075 MG/Day Weekly Transdermal SystemPSNdb4696da-7820-4b2b-97b4-fb05b12080203
238004estradiol 0.1 MG/Day Weekly Transdermal SystemPSNdb4696da-7820-4b2b-97b4-fb05b12080203
242333168 HR estradiol 0.00104 MG/HR Transdermal SystemSCDdb4696da-7820-4b2b-97b4-fb05b12080203
403922168 HR estradiol 0.00156 MG/HR Transdermal SystemSCDdb4696da-7820-4b2b-97b4-fb05b12080203
238003168 HR estradiol 0.00208 MG/HR Transdermal SystemSCDdb4696da-7820-4b2b-97b4-fb05b12080203
403923168 HR estradiol 0.0025 MG/HR Transdermal SystemSCDdb4696da-7820-4b2b-97b4-fb05b12080203
241527168 HR estradiol 0.00312 MG/HR Transdermal SystemSCDdb4696da-7820-4b2b-97b4-fb05b12080203
238004168 HR estradiol 0.00417 MG/HR Transdermal SystemSCDdb4696da-7820-4b2b-97b4-fb05b12080203
242333estradiol 0.025 MG/24HR Weekly Transdermal PatchSYdb4696da-7820-4b2b-97b4-fb05b12080203
242333estradiol 0.025 MG/Day Weekly Transdermal SystemSYdb4696da-7820-4b2b-97b4-fb05b12080203
403922estradiol 0.0375 MG/24HR Weekly Transdermal PatchSYdb4696da-7820-4b2b-97b4-fb05b12080203
403922estradiol 0.0375 MG/Day Weekly Transdermal SystemSYdb4696da-7820-4b2b-97b4-fb05b12080203
238003estradiol 0.05 MG/24HR Weekly Transdermal PatchSYdb4696da-7820-4b2b-97b4-fb05b12080203
238003estradiol 0.05 MG/Day Weekly Transdermal SystemSYdb4696da-7820-4b2b-97b4-fb05b12080203
403923estradiol 0.06 MG/24HR Weekly Transdermal PatchSYdb4696da-7820-4b2b-97b4-fb05b12080203
403923estradiol 0.06 MG/Day Weekly Transdermal SystemSYdb4696da-7820-4b2b-97b4-fb05b12080203
241527estradiol 0.075 MG/Day Weekly Transdermal PatchSYdb4696da-7820-4b2b-97b4-fb05b12080203
241527estradiol 0.075 MG/Day Weekly Transdermal SystemSYdb4696da-7820-4b2b-97b4-fb05b12080203
238004estradiol 0.1 MG per 24 HR Weekly Transdermal PatchSYdb4696da-7820-4b2b-97b4-fb05b12080203
238004estradiol 0.1 MG/Day Weekly Transdermal SystemSYdb4696da-7820-4b2b-97b4-fb05b12080203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-327-04683820327044 POUCH in 1 CARTON (68382-327-04) / 1 PATCH in 1 POUCH (68382-327-01) / 7 d in 1 PATCH4 pouch2023-11-02NoNoCurrent