Home NDC 70700-143 Estradiol
Product NDC 70700-143
11-digit product format 707000143
Labeler code 70700
Product ID 70700-143_6bb1aab9-ed96-51da-0e8a-b87af5450fdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol Gel 0.1%
Dosage form GEL
Route TOPICAL
Labeler Xiromed, LLC
Application ANDA211783
Marketing category ANDA
Marketing start 2022-10-01
Substance ESTRADIOL
Active strength .25 mg/.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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211783-001 ESTRADIOL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 A211783-002 ESTRADIOL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 A211783-003 ESTRADIOL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 2 · 51 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 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211783-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211783-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211783-003 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2022-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211783-001 ESTRADIOL 0.1% GEL / TRANSDERMAL AB 2022-08-10 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A211783-001 CGT 2023-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211783-001 CGT 2023-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211783-001 CGT 2023-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211783-001 CGT 2023-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211783-001 CGT 2023-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211783-001 CGT 2023-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211783-001 CGT 2023-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211783-001 CGT 2023-04-08 3a93d1ddd44b…
Additional Listing Data#
Finished product Yes
Brand name base Estradiol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .25 mg/.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 · 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 70700-143-35 Estradiol 30 in 1 CARTON GEL 30 9 70700-143-35 Estradiol 0.25 g in 1 PACKET GEL 0.25 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-143 ESTRADIOL (ESTRADIOL GEL 0.1%) GEL [XIROMED, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240517_1a46efe6-21b9-3f0f-90b9-59f279ef51df.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70700-143-35 70700014335 30 PACKET in 1 CARTON (70700-143-35) / .25 g in 1 PACKET 30 packet 2022-10-01 0000-00-00 No No Current