Home NDC 17139-617 EstroGel
Product NDC 17139-617
11-digit product format 171390617
Labeler code 17139
Product ID 17139-617_55240d4b-c38e-43ed-9d58-a9f5d453d2c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form GEL, METERED
Route TOPICAL
Labeler ASCEND Therapeutics US, LLC
Application NDA021166
Marketing category NDA
Marketing start 2004-02-09
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021166-001 ESTROGEL ESTRADIOL 0.06% GEL / TOPICAL 2004-02-09 N021166-002 ESTROGEL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021166-002 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 3 · 86 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 2026-09-14 22:38:34 2026-08 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB RLD, RS 2004-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL RLD, RS 2004-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL RLD, RS 2004-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL RLD, RS 2004-02-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021166-001 ESTROGEL 0.06% GEL / TOPICAL 2004-02-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021166-002 ESTROGEL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL RLD, RS 2004-02-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base EstroGel
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 226597 Internal RxNorm lookup 581549 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 17139-617-20 EstroGel 25 g in 1 BOTTLE, PUMP GEL, METERED 25 54 17139-617-40 EstroGel 50 g in 1 BOTTLE, PUMP GEL, METERED 50 54 17139-617-43 EstroGel 50 g in 1 BOTTLE, PUMP GEL, METERED 50 54 17139-617-43 EstroGel 3 in 1 CARTON GEL, METERED 3 54
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17139-617 ESTROGEL (ESTRADIOL) GEL, METERED [ASCEND THERAPEUTICS US, LLC] 51 Current NDC, Legacy NDC, 4 package rows 20240327_762ac371-bb8b-47e7-b48f-e80d452c9dd4.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EstroGel ESTRADIOL ASCEND Therapeutics US, LLC 762ac371-bb8b-47e7-b48f-e80d452c9dd4 2026-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021166 application number: NDA021166 ndc (product): 17139-617
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 17139-617-20 17139061720 25 g in 1 BOTTLE, PUMP 25 g Historical 17139-617-40 17139061740 50 g in 1 BOTTLE, PUMP (17139-617-40) 50 g 2004-02-09 0000-00-00 No No Current 17139-617-43 17139061743 50 g in 1 BOTTLE, PUMP 50 g Historical