Evamist

Product NDC
64011-215
11-digit product format
640110215
Labeler code
64011
Product ID
64011-215_9218e484-cb59-4bdc-a910-aeea2170646f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
SPRAY, METERED
Route
TRANSDERMAL
Labeler
Ther-Rx Corporation
Application
NDA022014
Marketing category
NDA
Marketing start
2009-07-08
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
2 mg/1
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64011-215DDiscontinued by firm2026-08-03
excluded packagepackage64011-21564011-215-41DDiscontinued by firm2026-08-03
excluded packagepackage64011-21564011-215-42DDiscontinued by firm2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64011-215-42DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64011-215-41DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64011-215-42DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64011-215-41DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64011-215-42DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64011-215-41DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64011-215-42DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64011-215-41DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64011-215-42DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64011-215-41DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64011-215-42DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64011-215-41DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64011-215-42DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64011-215-41DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64011-215-42DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64011-215-41DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64011-215-42DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64011-215-41DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64011-215-42DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64011-215-41DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64011-215-42DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64011-215-41DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64011-215-42DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64011-215-41DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64011-215-41IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64011-215-42IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64011-215-41IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64011-215-42IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022014-001EVAMISTESTRADIOL1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-273f01610625f2…
2019-09-15 20:21 UTC2019-09N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022014-001EVAMIST1.53MG/SPRAYSPRAY / TRANSDERMALRLD, RS2007-07-27cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022014-00169789452022-07-31Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022014-00169789452022-07-31Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022014-00169789452022-07-31Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022014-00169789452022-07-31Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022014-00169789452022-07-31Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022014-00169789452022-07-31Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022014-00169789452022-07-31Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N022014-00169789452022-07-31Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022014-00169789452022-07-31Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022014-00169789452022-07-31Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022014-00169789452022-07-31Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N022014-00169789452022-07-31Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N022014-00169789452022-07-31Drug productea99ee380514…
2023-01-26 05:58 UTC2023-01N022014-00169789452022-07-31Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022014-00169789452022-07-31Drug product3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022014-00169789452022-07-31Drug productf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022014-00169789452022-07-31Drug producte64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022014-00169789452022-07-31Drug productcb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64011-215-41ML - Milliliter64011-215a7731324-2e1c-42e5-ae0e-e741e2ea110712012-07-24

DailyMed Socrata Ingredients#

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EvamistESTRADIOLPadagis US LLC9a0aa631-133d-406b-9d32-8a1a99af4e502024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022014
application number: NDA022014