Home NDC 21922-088 Estradiol Gel
Product NDC 21922-088
11-digit product format 219220088
Labeler code 21922
Product ID 21922-088_5390c5ff-21e0-4b69-9e88-5593dbcbd9fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form GEL
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA218507
Marketing category ANDA
Marketing start 2025-03-10
Substance ESTRADIOL
Active strength .75 mg/.75g
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218507-001 ESTRADIOL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-002 ESTRADIOL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-003 ESTRADIOL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-004 ESTRADIOL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-005 ESTRADIOL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Estradiol Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .75 mg/.75g
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2619677 Internal RxNorm lookup 2619679 Internal RxNorm lookup 2619681 Internal RxNorm lookup 2619683 Internal RxNorm lookup 2619685 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 21922-088-52 Estradiol Gel 0.75 g in 1 PACKET GEL 0.75 5 21922-088-52 Estradiol Gel 30 in 1 CARTON GEL 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-088 ESTRADIOL GEL (ESTRADIOL) GEL [ENCUBE ETHICALS PRIVATE LIMITED] 3 Current NDC, 2 package rows 20250310_d4a3606f-83b2-45df-bc77-faebfa796f9a.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 · 1 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 21922-088-52 21922008852 30 PACKET in 1 CARTON (21922-088-52) / .75 g in 1 PACKET 30 packet 2025-03-10 No No Current