Home NDC 70954-646-10 Estradiol
Product NDC 70954-646
Requested package NDC 70954-646-10
11-digit product format 709540646
Labeler code 70954
Product ID 70954-646_3518120e-cc44-4d70-8a20-0ef2dce9a3c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form GEL, METERED
Route TOPICAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA217882
Marketing category ANDA
Marketing start 2024-10-23
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217882-001 ESTRADIOL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217882-001 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 2026-09-14 22:38:34 2026-08 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217882-001 ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED / TRANSDERMAL AB 2024-10-23 a50c72e98297…
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 Estradiol
Listing expiration 2026-12-31 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 70954-646-10 Estradiol 50 g in 1 BOTTLE, PUMP GEL, METERED 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-646 ESTRADIOL GEL, METERED [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20241030_3518120e-cc44-4d70-8a20-0ef2dce9a3c6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-646-10 70954064610 50 g in 1 BOTTLE, PUMP (70954-646-10) 50 g 2024-10-23 No No Current