Home NDC 12822-0313 ANNOVERA
Product NDC 12822-0313
11-digit product format 128220313
Labeler code 12822
Product ID 12822-0313_90b50883-bb8c-47a1-e053-2995a90a1651
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SEGESTERONE ACETATE, ETHINYL ESTRADIOL
Dosage form RING
Route VAGINAL
Labeler QPharma AB
Application NDA209627
Marketing category NDA
Marketing start 2019-08-08
Marketing end 0000-00-00
Substance SEGESTERONE ACETATE; ETHINYL ESTRADIOL
Active strength 103 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA],Estrogen [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 12822-0313 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 12822-0313 12822-0313-1 UNFINISHED Active or certified unfinished drug listing 2026-10-05
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 · 38 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 12822-0313-1 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 12822-0313-1 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 12822-0313-1 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 12822-0313-1 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 12822-0313-1 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 12822-0313-1 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 12822-0313-1 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 12822-0313-1 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 12822-0313-1 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 12822-0313-1 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 12822-0313-1 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 12822-0313-1 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 12822-0313-1 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 12822-0313-1 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 12822-0313-1 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 12822-0313-1 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 12822-0313-1 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 12822-0313-1 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 12822-0313-1 4bd3596a7b87…5c64c6f6865f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209627-001 ANNOVERA 0.013MG/24HR;0.15MG/24HR RING / VAGINAL RLD, RS 2018-08-10 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 10 · 393 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209627-001 10632066 2039-02-01 U-2787 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10632066 2039-02-01 U-2786 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10765628 2039-02-01 U-2786 2020-09-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10765628 2039-02-01 U-2787 2020-09-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10780047 2039-02-01 U-2787 2020-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10780047 2039-02-01 U-2786 2020-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10918649 2039-06-21 Drug product 2021-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10925882 2039-06-21 Drug product 2021-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 10940157 2039-06-21 Drug product 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 11529308 2039-06-21 Drug product 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 11850251 2039-06-21 U-3785 2024-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209627-001 12303518 2039-06-21 Drug product 2025-07-09 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEGESTERONE ACETATE 103 mg/1 ETHINYL ESTRADIOL 17.4 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 12822-0313-1 12822031301 1 POUCH in 1 CARTON (12822-0313-1) / 1 RING in 1 POUCH 1 pouch 08-AUG-19 Current