Home NDC 59651-439 ESTRADIOL VAGINAL INSERTS
Product NDC 59651-439
11-digit product format 596510439
Labeler code 59651
Product ID 59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form TABLET, FILM COATED
Route VAGINAL
Labeler Aurobindo Pharma Limited
Application ANDA216550
Marketing category ANDA
Marketing start 2024-08-02
Substance ESTRADIOL HEMIHYDRATE
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 A216550-001 ESTRADIOL ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216550-001 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.
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 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216550-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2024-08-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ESTRADIOL VAGINAL INSERTS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL HEMIHYDRATE 10 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CXY7B3Q98Z 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 59651-439-08 ESTRADIOL VAGINAL INSERTS 1 in 1 APPLICATOR TABLET, FILM COATED 1 3 59651-439-08 ESTRADIOL VAGINAL INSERTS 8 in 1 CARTON TABLET, FILM COATED 8 3 59651-439-18 ESTRADIOL VAGINAL INSERTS 1 in 1 APPLICATOR TABLET, FILM COATED 1 3 59651-439-18 ESTRADIOL VAGINAL INSERTS 18 in 1 CARTON TABLET, FILM COATED 18 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-439 ESTRADIOL VAGINAL INSERTS (ESTRADIOL) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 Current NDC, 4 package rows 20240817_6247e329-e20e-4ea5-9cc1-b593bd494577.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 Sample Exclude flag Status 59651-439-08 59651043908 8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR 8 applicator 2024-08-02 No No Current 59651-439-18 59651043918 18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR 18 applicator 2024-08-02 No No Current