Home NDC 53746-226 Estradiol
Product NDC 53746-226
11-digit product format 537460226
Labeler code 53746
Product ID 53746-226_eb2cbf77-ea3e-4604-9271-cd2228059e30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form INSERT
Route VAGINAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA205256
Marketing category ANDA
Marketing start 2015-06-07
Substance ESTRADIOL
Active strength 10 ug/1
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 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 A205256-001 ESTRADIOL ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205256-001 AB
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 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205256-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2015-05-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Estradiol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL 10 ug/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884707 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 53746-226-21 Estradiol 1 in 1 APPLICATOR INSERT 1 14 53746-226-21 Estradiol 8 in 1 CARTON INSERT 8 14 53746-226-23 Estradiol 1 in 1 APPLICATOR INSERT 1 14 53746-226-23 Estradiol 18 in 1 CARTON INSERT 18 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-226 ESTRADIOL INSERT [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 14 Current NDC, Legacy NDC, 4 package rows 20250108_094830ee-1b1c-4cf7-8a39-427dfd56f9c9.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 · 3 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 53746-226-21 53746022621 8 APPLICATOR in 1 CARTON (53746-226-21) / 1 INSERT in 1 APPLICATOR 8 applicator 2015-06-07 0000-00-00 No No Current 53746-226-23 53746022623 18 APPLICATOR in 1 CARTON (53746-226-23) / 1 INSERT in 1 APPLICATOR 18 applicator 2015-06-07 0000-00-00 No No Current