Estradiol

Product NDC
68071-3326
11-digit product format
680713326
Labeler code
68071
Product ID
68071-3326_95330f13-c236-f218-e053-2995a90a814c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA020538
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-22
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
0 mg/d
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-3326DDiscontinued by firm2026-11-12
excluded packagepackage68071-332668071-3326-8DDiscontinued by firm2026-11-12

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-3326-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-3326-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-3326-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-3326-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-3326-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-3326-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-3326-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-3326-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-3326-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-3326-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-3326-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3326-8557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020538-005VIVELLE-DOTESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08
N020538-006VIVELLE-DOTESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08
N020538-007VIVELLE-DOTESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08
N020538-008VIVELLE-DOTESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-08
N020538-009VIVELLE-DOTESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N020538-005AB1
N020538-006AB1
N020538-007AB1
N020538-008AB1
N020538-009AB1

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 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08c2088c7a36db…
2026-10-15 13:18:302026-09N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08c2088c7a36db…
2026-10-15 13:18:302026-09N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08c2088c7a36db…
2026-10-15 13:18:302026-09N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-08c2088c7a36db…
2026-10-15 13:18:302026-09N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-03c2088c7a36db…
2026-09-14 22:38:342026-08N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-0384e616aacf4f…
2026-08-18 06:07:402026-07N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-005VIVELLE-DOT0.0375MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-006VIVELLE-DOT0.05MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-007VIVELLE-DOT0.075MG/24HRSYSTEM / TRANSDERMALAB1RLD1999-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-008VIVELLE-DOT0.1MG/24HRSYSTEM / TRANSDERMALAB1RLD, RS1999-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-009VIVELLE-DOT0.025MG/24HRSYSTEM / TRANSDERMALAB1RLD2002-05-03b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020538-005AB11c2088c7a36db…
2026-10-15 13:18:302026-09N020538-006AB11c2088c7a36db…
2026-10-15 13:18:302026-09N020538-007AB11c2088c7a36db…
2026-10-15 13:18:302026-09N020538-008AB11c2088c7a36db…
2026-10-15 13:18:302026-09N020538-009AB11c2088c7a36db…
2026-09-14 22:38:342026-08N020538-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08N020538-006AB1184e616aacf4f…
2026-09-14 22:38:342026-08N020538-007AB1184e616aacf4f…
2026-09-14 22:38:342026-08N020538-008AB1184e616aacf4f…
2026-09-14 22:38:342026-08N020538-009AB1184e616aacf4f…
2026-08-18 06:07:402026-07N020538-005AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-006AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-007AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-008AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N020538-009AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020538-005AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-006AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-007AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-008AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020538-009AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-005AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-006AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-007AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-008AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020538-009AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020538-005AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-006AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-007AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-008AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020538-009AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-005AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-006AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-007AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-008AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020538-009AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-005AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-006AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-007AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-008AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020538-009AB11b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#