Home NDC 64011-215 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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64011-215-42 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64011-215-41 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64011-215-42 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64011-215-41 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64011-215-42 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64011-215-41 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64011-215-42 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64011-215-41 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64011-215-42 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64011-215-41 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64011-215-42 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64011-215-41 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64011-215-42 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64011-215-41 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64011-215-42 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64011-215-41 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64011-215-42 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64011-215-41 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64011-215-42 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64011-215-41 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64011-215-42 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64011-215-41 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64011-215-42 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64011-215-41 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 64011-215-41 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 64011-215-42 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 64011-215-41 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 64011-215-42 I Inactivated by FDA 9bebd1f3094a…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022014-001 EVAMIST ESTRADIOL 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27
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 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 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022014-001 EVAMIST 1.53MG/SPRAY SPRAY / TRANSDERMAL RLD, RS 2007-07-27 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022014-001 6978945 2022-07-31 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022014-001 6978945 2022-07-31 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022014-001 6978945 2022-07-31 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022014-001 6978945 2022-07-31 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022014-001 6978945 2022-07-31 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022014-001 6978945 2022-07-31 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022014-001 6978945 2022-07-31 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022014-001 6978945 2022-07-31 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022014-001 6978945 2022-07-31 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022014-001 6978945 2022-07-31 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022014-001 6978945 2022-07-31 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022014-001 6978945 2022-07-31 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022014-001 6978945 2022-07-31 Drug product ea99ee380514…2023-01-26 05:58 UTC 2023-01 N022014-001 6978945 2022-07-31 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022014-001 6978945 2022-07-31 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022014-001 6978945 2022-07-31 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022014-001 6978945 2022-07-31 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022014-001 6978945 2022-07-31 Drug product cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded estradiol ACTIVE INGREDIENT 4TI98Z838E EVAMIST (ESTRADIOL) SPRAY, METERED [THER-RX CORPORATION] 12 estradiol ACTIVE MOIETY 4TI98Z838E EVAMIST (ESTRADIOL) SPRAY, METERED [THER-RX CORPORATION] 12 alcohol INACTIVE INGREDIENT 3K9958V90M EVAMIST (ESTRADIOL) SPRAY, METERED [THER-RX CORPORATION] 12 octisalate INACTIVE INGREDIENT 4X49Y0596W EVAMIST (ESTRADIOL) SPRAY, METERED [THER-RX CORPORATION] 12 ESTRADIOL ACTIVE INGREDIENT 4TI98Z838E EVAMIST (ESTRADIOL) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 ESTRADIOL ACTIVE MOIETY 4TI98Z838E EVAMIST (ESTRADIOL) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M EVAMIST (ESTRADIOL) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 OCTISALATE INACTIVE INGREDIENT 4X49Y0596W EVAMIST (ESTRADIOL) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Evamist ESTRADIOL Padagis US LLC 9a0aa631-133d-406b-9d32-8a1a99af4e50 2024-10-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022014 application number: NDA022014