Home NDC 21922-015 ESTRADIOL
Product NDC 21922-015
11-digit product format 219220015
Labeler code 21922
Product ID 21922-015_d03184c7-c726-4356-a643-bd4bdd0f893b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form GEL
Route TRANSDERMAL
Labeler Encube Ethicals, Inc.
Application ANDA218214
Marketing category ANDA
Marketing start 2026-05-13
Substance ESTRADIOL
Active strength .75 mg/1.25g
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218214-001 ESTRADIOL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2026-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218214-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218214-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2026-05-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218214-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ESTRADIOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .75 mg/1.25g
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 226597 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 21922-015-40 ESTRADIOL 50 g in 1 BOTTLE, PUMP GEL 50 3 21922-015-40 ESTRADIOL 1 in 1 CARTON GEL 1 3
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 Marketing start Sample Exclude flag Status 21922-015-40 21922001540 1 BOTTLE, PUMP in 1 CARTON (21922-015-40) / 50 g in 1 BOTTLE, PUMP 2026-05-13 No No Current