Home NDC 50090-8003 Estradiol / Norethindrone Acetate
Product NDC 50090-8003
11-digit product format 500908003
Labeler code 50090
Product ID 50090-8003_0f230825-81ed-43c2-b9ef-4df23b85f347
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol and Norethindrone Acetate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078324
Marketing category ANDA
Marketing start 2008-04-17
Substance ESTRADIOL; NORETHINDRONE ACETATE
Active strength 1; .5 mg/1; mg/1
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078324-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2008-04-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078324-002 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2011-06-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 / Norethindrone Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL 1 mg/1 NORETHINDRONE ACETATE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4TI98Z838E Internal UNII lookup 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359126 Internal RxNorm lookup 1359127 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8003-0 50090800300 1 BLISTER PACK in 1 CARTON (50090-8003-0) / 28 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-06-25 No No Current