Home NDC 0781-7144 Estradiol
Product NDC 0781-7144
11-digit product format 007817144
Labeler code 0781
Product ID 0781-7144_8ca8b0a3-4e48-4d54-91b9-d2ea02aaa367
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Sandoz Inc
Application NDA020538
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-12-22
Substance ESTRADIOL
Active strength .05 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
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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 N020538-005 VIVELLE-DOT ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 N020538-006 VIVELLE-DOT ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 N020538-007 VIVELLE-DOT ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 N020538-008 VIVELLE-DOT ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 N020538-009 VIVELLE-DOT ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03
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 · 215 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 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .05 mg/d
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-7144-40 Estradiol 3 in 1 CARTON PATCH, EXTENDED RELEASE 3 11 0781-7144-40 Estradiol 8 in 1 CARTON PATCH, EXTENDED RELEASE 8 11 0781-7144-58 Estradiol 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 11 0781-7144-58 Estradiol 3.5 d in 1 PATCH PATCH, EXTENDED RELEASE 3.5 11 0781-7144-83 Estradiol 8 in 1 CARTON PATCH, EXTENDED RELEASE 8 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-7144 ESTRADIOL PATCH, EXTENDED RELEASE [SANDOZ INC] 11 Current NDC, Legacy NDC, 5 package rows 20250214_c4da6de7-9ab1-4fcf-88f3-fe785019e6e7.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 Marketing end Sample Exclude flag Status 0781-7144-40 00781714440 3 PACKET in 1 CARTON (0781-7144-40) > 8 POUCH in 1 PACKET (0781-7144-83) > 1 PATCH in 1 POUCH (0781-7144-58) > 3.5 d in 1 PATCH 3 packet 2014-12-22 0000-00-00 No No Current 0781-7144-58 00781714458 1 in 1 POUCH Historical 0781-7144-83 00781714483 8 POUCH in 1 CARTON (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH 8 pouch 2014-12-22 No No Current