Home DailyMed 301c619d-a2d1-47ae-8adc-dafd3fcc54f9 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-05-02
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:06:28 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203505-001 OSPHENA 60MG TABLET / ORAL RLD, RS 2013-02-26 84e616aacf4f…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 691 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N203505-001 8236861 2026-08-11 U-905 2013-03-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203505-001 8236861 2026-08-11 U-905 2013-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203505-001 8236861 2026-08-11 U-1369 2013-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203505-001 8236861 2026-08-11 U-1370 2013-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203505-001 8642079 2028-07-09 Drug product 2014-02-20 84e616aacf4f…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.