Home NDC 72603-243-30 Estradiol
Product NDC 72603-243
Requested package NDC 72603-243-30
11-digit product format 726030243
Labeler code 72603
Product ID 72603-243_37b3aa97-b1e5-fe8e-e063-6294a90a48c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form GEL
Route TOPICAL
Labeler NorthStar Rx LLC
Application ANDA217610
Marketing category ANDA
Marketing start 2023-12-18
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 2026-12-31
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 A217610-001 ESTRADIOL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 A217610-002 ESTRADIOL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 A217610-003 ESTRADIOL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 A217610-004 ESTRADIOL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 A217610-005 ESTRADIOL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24
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 · 78 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 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217610-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217610-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217610-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217610-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217610-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2023-08-24 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 2026-12-31 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 72603-243-01 Estradiol 0.75 g in 1 PACKET GEL 0.75 4 72603-243-30 Estradiol 30 in 1 CARTON GEL 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-243 ESTRADIOL GEL [NORTHSTAR RX LLC] 3 Current NDC, 2 package rows 20240516_0c8a07a4-5762-eaf4-e063-6394a90a54ff.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 · 2 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 72603-243-30 72603024330 30 PACKET in 1 CARTON (72603-243-30) / .75 g in 1 PACKET (72603-243-01) 30 packet 2023-12-18 No No Current