Home NDC 75929-178 Osphena
Product NDC 75929-178
11-digit product format 759290178
Labeler code 75929
Product ID 75929-178_d8109817-1594-59f0-e053-2a95a90ac0a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ospemifene
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pharma Packaging Solutions
Application NDA203505
Marketing category NDA
Marketing start 2013-02-26
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Osphena OSPEMIFENE Duchesnay USA, Inc. 9accbcc9-78ee-4f84-9b7e-704f2ab1c413 2025-02-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203505 application number: NDA203505
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75929-178-09 75929017809 90 TABLET, FILM COATED in 1 BOTTLE (75929-178-09) 2013-02-26 0000-00-00 No No Current 75929-178-95 75929017895 1 BLISTER PACK in 1 PACKAGE (75929-178-95) > 5 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-04-15 0000-00-00 No No Current