Home NDC 70771-1567-8 Estradiol
Product NDC 70771-1567
Requested package NDC 70771-1567-8
11-digit product format 707711567
Labeler code 70771
Product ID 70771-1567_260eb67a-a1fc-4dae-9f69-345ea6ad9f83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Zydus Lifesciences Limited
Application ANDA206241
Marketing category ANDA
Marketing start 2023-04-13
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 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206241-001 ESTRADIOL ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 A206241-002 ESTRADIOL ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 A206241-003 ESTRADIOL ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 A206241-004 ESTRADIOL ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 A206241-005 ESTRADIOL ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01
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 4 · 130 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 2026-09-14 22:38:34 2026-08 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206241-001 ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206241-002 ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206241-003 ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206241-004 ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206241-005 ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 2022-12-01 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 130 observed states.
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 Ingredient Strength ESTRADIOL .1 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 70771-1567-1 Estradiol 3.5 d in 1 PATCH PATCH, EXTENDED RELEASE 3.5 1 70771-1567-1 Estradiol 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 1 70771-1567-8 Estradiol 8 in 1 BOX PATCH, EXTENDED RELEASE 8 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1567 ESTRADIOL PATCH, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 3 package rows 20230413_b79fd5ea-962f-491c-b670-40efe42ccf79.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70771-1567-8 70771156708 8 POUCH in 1 BOX (70771-1567-8) / 1 PATCH in 1 POUCH (70771-1567-1) / 3.5 d in 1 PATCH 8 pouch 2023-04-13 No No Current