Home NDC 50090-7610-0 Estradiol
Product NDC 50090-7610
Requested package NDC 50090-7610-0
11-digit product format 500907610
Labeler code 50090
Product ID 50090-7610_9db02f59-f5e3-42ab-8a25-a204b04a1e34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form FILM, EXTENDED RELEASE
Route TRANSDERMAL
Labeler A-S Medication Solutions
Application NDA203752
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-01-01
Substance ESTRADIOL
Active strength .0375 mg/d
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 45 .
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 N203752-001 MINIVELLE ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 N203752-002 MINIVELLE ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 N203752-003 MINIVELLE ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 N203752-004 MINIVELLE ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 N203752-005 MINIVELLE ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203752-001 9730900 2028-07-10 U-2086 2017-08-18 N203752-001 9833419 2028-07-10 Drug product 2017-12-14 N203752-001 8231906 2030-07-04 Drug substance, Drug product 2013-03-22 N203752-002 9730900 2028-07-10 U-2086 2017-08-18 N203752-002 9833419 2028-07-10 Drug product 2017-12-14 N203752-002 8231906 2030-07-04 Drug substance, Drug product N203752-003 9730900 2028-07-10 U-2086 2017-08-18 N203752-003 9833419 2028-07-10 Drug product 2017-12-14 N203752-003 8231906 2030-07-04 Drug substance, Drug product N203752-004 9730900 2028-07-10 U-2086 2017-08-18 N203752-004 9833419 2028-07-10 Drug product 2017-12-14 N203752-004 8231906 2030-07-04 Drug substance, Drug product N203752-005 9724310 2028-07-10 Drug substance, Drug product 2017-08-18 N203752-005 9730900 2028-07-10 U-2086 Drug product 2017-08-18 N203752-005 9833419 2028-07-10 Drug product 2017-12-14 N203752-005 8231906 2030-07-04 Drug substance, Drug product 2015-05-08
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 6 · 225 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 2026-11-14 07:37:17 2026-10 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203752-001 MINIVELLE 0.0375MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203752-002 MINIVELLE 0.075MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203752-003 MINIVELLE 0.05MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2012-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203752-004 MINIVELLE 0.1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD, RS 2012-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203752-005 MINIVELLE 0.025MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL AB3 RLD 2014-09-23 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 225 observed states.
Observed Orange Book patent history# Patent history page 1 of 19 · 750 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-11-14 07:37:17 2026-10 N203752-001 9730900 2028-07-10 U-2086 2017-08-18 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-001 9833419 2028-07-10 Drug product 2017-12-14 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-001 8231906 2030-07-04 Drug substance, Drug product 2013-03-22 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-002 9730900 2028-07-10 U-2086 2017-08-18 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-002 9833419 2028-07-10 Drug product 2017-12-14 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-002 8231906 2030-07-04 Drug substance, Drug product d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-003 9730900 2028-07-10 U-2086 2017-08-18 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-003 9833419 2028-07-10 Drug product 2017-12-14 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-003 8231906 2030-07-04 Drug substance, Drug product d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-004 9730900 2028-07-10 U-2086 2017-08-18 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-004 9833419 2028-07-10 Drug product 2017-12-14 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-004 8231906 2030-07-04 Drug substance, Drug product d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-005 9724310 2028-07-10 Drug substance, Drug product 2017-08-18 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-005 9730900 2028-07-10 U-2086 Drug product 2017-08-18 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-005 9833419 2028-07-10 Drug product 2017-12-14 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N203752-005 8231906 2030-07-04 Drug substance, Drug product 2015-05-08 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N203752-001 9730900 2028-07-10 U-2086 2017-08-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-001 9833419 2028-07-10 Drug product 2017-12-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-001 8231906 2030-07-04 Drug substance, Drug product 2013-03-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-002 9730900 2028-07-10 U-2086 2017-08-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-002 9833419 2028-07-10 Drug product 2017-12-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-002 8231906 2030-07-04 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-003 9730900 2028-07-10 U-2086 2017-08-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-003 9833419 2028-07-10 Drug product 2017-12-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-003 8231906 2030-07-04 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-004 9730900 2028-07-10 U-2086 2017-08-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-004 9833419 2028-07-10 Drug product 2017-12-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-004 8231906 2030-07-04 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-005 9724310 2028-07-10 Drug substance, Drug product 2017-08-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-005 9730900 2028-07-10 U-2086 Drug product 2017-08-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-005 9833419 2028-07-10 Drug product 2017-12-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203752-005 8231906 2030-07-04 Drug substance, Drug product 2015-05-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203752-001 9730900 2028-07-10 U-2086 2017-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-001 9833419 2028-07-10 Drug product 2017-12-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-001 8231906 2030-07-04 Drug substance, Drug product 2013-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-002 9730900 2028-07-10 U-2086 2017-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-002 9833419 2028-07-10 Drug product 2017-12-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-002 8231906 2030-07-04 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-003 9730900 2028-07-10 U-2086 2017-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203752-003 9833419 2028-07-10 Drug product 2017-12-14 84e616aacf4f…
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 .0375 mg/d
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 241946 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 50090-7610-0 Estradiol 1 d in 1 POUCH FILM, EXTENDED RELEASE 1 1 50090-7610-0 Estradiol 8 in 1 CARTON FILM, EXTENDED RELEASE 8 1
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Minivelle ESTRADIOL Noven Therapeutics, LLC 6c5c47ab-28ee-11e1-bfc2-0800200c9a66 2026-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203752 application number: NDA203752 Estradiol ESTRADIOL A-S Medication Solutions 13f9c41b-417c-45e4-9a59-baf774fca78d 2025-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203752 application number: NDA203752 ndc (package): 50090-7610-0 ndc (product): 50090-7610 ndc11 (package): 50090761000 Estradiol ESTRADIOL Noven Therapeutics, LLC bf185599-2138-4083-9c52-2b95dce09ae0 2024-04-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203752 application number: NDA203752
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7610-0 50090761000 8 POUCH in 1 CARTON (50090-7610-0) / 1 d in 1 POUCH 8 pouch 2025-07-22 No No Current