ANNOVERA

Product NDC: 12822-0313
Requested package NDC: 12822-0313-1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	12822-0313	12822-0313-1	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209627-001	NCE	2023-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209627-001	NCE	2023-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209627-001	NCE	2023-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209627-001	NCE	2023-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209627-001	NCE	2023-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209627-001	NCE	2023-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209627-001	NCE	2023-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209627-001	NCE	2023-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209627-001	NCE	2023-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209627-001	NCE	2023-08-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209627-001	NCE	2023-08-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209627-001	NCE	2023-08-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209627-001	NCE	2023-08-10	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N209627-001	NCE	2023-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209627-001	NCE	2023-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209627-001	NCE	2023-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209627-001	NCE	2023-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209627-001	NCE	2023-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209627-001	NCE	2023-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209627-001	NCE	2023-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209627-001	NCE	2023-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209627-001	NCE	2023-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209627-001	NCE	2023-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209627-001	NCE	2023-08-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEGESTERONE ACETATE	17.4 mg/1
ETHINYL ESTRADIOL	103 mg/1

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9AMX4Q13CC	SEGESTERONE ACETATE	7759-35-5	SEGESTERONE ACETATE
423D2T571U	ETHINYL ESTRADIOL	57-63-6	ETHINYL ESTRADIOL

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