Home NDC 0378-4641 Estradiol
Product NDC 0378-4641
11-digit product format 003784641
Labeler code 0378
Product ID 0378-4641_e1deb37a-8362-4275-a04c-7abcbb2e9f56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form PATCH
Route TRANSDERMAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA201675
Marketing category ANDA
Marketing start 2014-12-19
Substance ESTRADIOL
Active strength .075 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 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201675-001 ESTRADIOL ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 A201675-002 ESTRADIOL ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 A201675-003 ESTRADIOL ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 A201675-004 ESTRADIOL ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 A201675-005 ESTRADIOL ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201675-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201675-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201675-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201675-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201675-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2014-12-19 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Estradiol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .075 mg/d
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4TI98Z838E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 241946 Internal RxNorm lookup 242891 Internal RxNorm lookup 242892 Internal RxNorm lookup 248478 Internal RxNorm lookup 1149632 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-4641-16 Estradiol 3.5 d in 1 PATCH PATCH 3.5 14 0378-4641-16 Estradiol 1 in 1 POUCH PATCH 1 14 0378-4641-26 Estradiol 8 in 1 CARTON PATCH 8 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4641 ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 3 package rows 20241220_d28bec8f-762e-4f05-a20d-96a42970d6a7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-4641-16 00378464116 3.5 d in 1 PATCH 3.5 d Historical 0378-4641-26 00378464126 8 POUCH in 1 CARTON (0378-4641-26) / 1 PATCH in 1 POUCH (0378-4641-16) / 3.5 d in 1 PATCH 8 pouch 2014-12-19 0000-00-00 No No Current