Home NDC 50090-2321-0 ESTRACE
Product NDC 50090-2321
Requested package NDC 50090-2321-0
11-digit product format 500902321
Labeler code 50090
Product ID 50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form CREAM
Route VAGINAL
Labeler A-S Medication Solutions
Application ANDA086069
Marketing category ANDA
Marketing start 2001-07-01
Substance ESTRADIOL
Active strength .1 mg/g
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2321 50090-2321-0 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A086069-001 ESTRACE ESTRADIOL 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A086069-001 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.
Product history page 1 of 2 · 41 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 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RS 1984-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086069-001 ESTRACE 0.01% CREAM / VAGINAL AB RLD, RS 1984-01-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ESTRACE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .1 mg/g
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 310169 Internal RxNorm lookup 890918 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2321-0 ESTRACE 1 in 1 CARTON CREAM 1 20 50090-2321-0 ESTRACE 42.5 g in 1 TUBE CREAM 42.5 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2321 ESTRACE (ESTRADIOL) CREAM [A-S MEDICATION SOLUTIONS] 20 Current NDC, Legacy NDC, 2 package rows 20240813_da52a602-f2a2-4382-be07-30351c58cc4b.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Estradiol ESTRADIOL Teva Pharmaceuticals USA, Inc. c94738ff-dece-4fb6-bb44-4f8832a45f38 2025-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 086069 application number: ANDA086069 ESTRACE ESTRADIOL A-S Medication Solutions da52a602-f2a2-4382-be07-30351c58cc4b 2024-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 086069 application number: ANDA086069 ndc (package): 50090-2321-0 ndc (product): 50090-2321 ndc11 (package): 50090232100 Estradiol ESTRADIOL A-S Medication Solutions c8a2d29c-299c-4559-b859-87b303a4af81 2024-07-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 086069 application number: ANDA086069 ESTRACE ESTRADIOL Allergan, Inc. dfc41fcd-c5ba-4b25-b647-cf04d3988b3e 2024-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 086069 application number: ANDA086069
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 50090-2321-0 50090232100 1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE 1 tube 2016-03-02 0000-00-00 No No Current