Home NDC 69238-2450 Estradiol
Product NDC 69238-2450
11-digit product format 692382450
Labeler code 69238
Product ID 69238-2450_cebb61d3-34b7-44a7-aae7-d23e21651713
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol Transdermal
Dosage form GEL
Route TOPICAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216055
Marketing category ANDA
Marketing start 2024-07-15
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 43 .
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 A216055-001 ESTRADIOL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-002 ESTRADIOL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-003 ESTRADIOL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-004 ESTRADIOL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-005 ESTRADIOL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12
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.
Product history page 1 of 2 · 70 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 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
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 Estradiol
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 69238-2450-1 Estradiol 0.75 g in 1 PACKET GEL 0.75 12 69238-2450-3 Estradiol 30 in 1 CARTON GEL 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2450 ESTRADIOL (ESTRADIOL TRANSDERMAL) GEL [AMNEAL PHARMACEUTICALS NY LLC] 10 Current NDC, 2 package rows 20240715_9669a0e3-27e2-4f6c-961c-7a67e9f84cc8.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 Estradiol ESTRADIOL TRANSDERMAL Amneal Pharmaceuticals NY LLC 9669a0e3-27e2-4f6c-961c-7a67e9f84cc8 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216055 application number: ANDA216055 ndc (product): 69238-2450
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69238-2450-1 69238245001 0.75 g in 1 PACKET 0.75 g Historical 69238-2450-3 69238245003 30 PACKET in 1 CARTON (69238-2450-3) / .75 g in 1 PACKET (69238-2450-1) 30 packet 2024-07-15 No No Current