Home NDC 50261-313 ANNOVERA
Product NDC 50261-313
11-digit product format 502610313
Labeler code 50261
Product ID 50261-313_17feae6d-baa1-4f2c-8989-c5400c2a1a88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name segesterone acetate and ethinyl estradiol
Dosage form RING
Route VAGINAL
Labeler TherapeuticsMD, Inc.
Application NDA209627
Marketing category NDA
Marketing start 2019-08-12
Marketing end 0000-00-00
Substance ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Active strength 17 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50261-313-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50261-313-01 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N209627-001 ANNOVERA ETHINYL ESTRADIOL; SEGESTERONE ACETATE 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209627-001 10632066 2039-02-01 U-2786 2020-04-29 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 N209627-001 12303518 2039-06-21 Drug product 2025-07-09
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 10 · 369 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 fd3edfee7708…
Observed Orange Book exclusivity history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50261-313 ANNOVERA (SEGESTERONE ACETATE AND ETHINYL ESTRADIOL) RING [THERAPEUTICSMD, INC.] 6 Legacy NDC 20220824_37bb9ebd-2e99-4453-bbe6-9dd4a2897193.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Annovera SEGESTERONE ACETATE AND ETHINYL ESTRADIOL Mayne Pharma eb18194f-2021-41fa-8bdf-31e0c0eb646b 2025-04-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209627 application number: NDA209627
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50261-313-01 50261031301 1 POUCH in 1 CARTON (50261-313-01) > 1 RING in 1 POUCH 1 pouch 2019-08-12 0000-00-00 No No Current