Home NDC 55494-580 Osphena
Product NDC 55494-580
11-digit product format 554940580
Labeler code 55494
Product ID 55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ospemifene
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Duchesnay USA, Inc.
Application NDA203505
Marketing category NDA
Marketing start 2023-04-01
Substance OSPEMIFENE
Active strength 60 mg/1
Pharmacologic classes Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
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 42 .
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 N203505-001 OSPHENA OSPEMIFENE 60MG TABLET / ORAL RLD, RS 2013-02-26
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203505-001 8236861 2026-08-11 U-1369 2013-03-25 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 N203505-001 8236861 2026-08-11 U-905 2013-03-25 N203505-001 8642079 2028-07-09 Drug product 2014-02-20
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 · 42 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 2026-08-18 06:07:40 2026-07 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203505-001 OSPHENA 60MG TABLET / ORAL AB RLD, RS 2013-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 683 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N203505-001 8236861 2026-08-11 U-905 2013-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203505-001 8236861 2026-08-11 U-905 2013-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 6245819 2025-07-21 U-905 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 6245819 2025-07-21 U-1370 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 8236861 2026-08-11 U-905 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203505-001 6245819 2025-07-21 U-905 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203505-001 6245819 2025-07-21 U-1370 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203505-001 8236861 2026-08-11 U-905 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 6245819 2025-07-21 U-905 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 6245819 2025-07-21 U-1370 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 8236861 2026-08-11 U-905 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 6245819 2025-07-21 U-905 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 6245819 2025-07-21 U-1370 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 8236861 2026-08-11 U-905 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 8470890 2024-02-13 U-905 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 8470890 2024-02-13 U-1370 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 8470890 2024-02-13 U-1369 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 8772353 2024-02-13 U-1370 2014-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 8772353 2024-02-13 U-905 2014-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 8772353 2024-02-13 U-1369 2014-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 9241915 2024-02-13 U-1369 2016-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203505-001 9241915 2024-02-13 U-1370 2016-02-10 03ed91905a0d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Osphena
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSPEMIFENE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B0P231ILBK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370976 Internal RxNorm lookup 1370982 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 55494-580-18 Osphena 15 in 1 BLISTER PACK TABLET, FILM COATED 15 4 55494-580-18 Osphena 1 in 1 PACKAGE TABLET, FILM COATED 1 4 55494-580-30 Osphena 30 in 1 BOTTLE TABLET, FILM COATED 30 4 55494-580-55 Osphena 1 in 1 PACKAGE TABLET, FILM COATED 1 4 55494-580-55 Osphena 5 in 1 BLISTER PACK TABLET, FILM COATED 5 4 55494-580-90 Osphena 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55494-580 OSPHENA (OSPEMIFENE) TABLET, FILM COATED [DUCHESNAY USA, INC.] 4 Current NDC, 6 package rows 20250216_9accbcc9-78ee-4f84-9b7e-704f2ab1c413.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 55494-580-18 55494058018 1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2023-04-01 Yes No Current 55494-580-30 55494058030 30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30) 2023-08-01 No No Current 55494-580-55 55494058055 1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2023-04-01 Yes No Current 55494-580-90 55494058090 90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90) 2023-04-01 No No Current