Annovera

Product NDC: 68308-752
11-digit product format: 683080752
Labeler code: 68308
Product ID: 68308-752_88f47600-fe7d-4744-be8d-e29dde1711e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: segesterone acetate and ethinyl estradiol
Dosage form: RING
Route: VAGINAL
Labeler: Mayne Pharma
Application: NDA209627
Marketing category: NDA
Marketing start: 2024-08-16
Substance: ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Active strength: 17.4; 103 mg/1; mg/1
Pharmacologic classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Yes
Brand name base: Annovera
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9AMX4Q13CC	Internal UNII lookup
423D2T571U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2055983	Internal RxNorm lookup
2055989	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eb18194f-2021-41fa-8bdf-31e0c0eb646b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68308-752-01	Annovera	1 in 1 CARTON	RING	1		5
68308-752-01	Annovera	30 in 1 POUCH	RING	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-752-01	EA - Each	68308-752	ed6f0ae0-5dab-4cb9-aabc-3cad820f9d00	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68308-752	ANNOVERA (SEGESTERONE ACETATE AND ETHINYL ESTRADIOL) RING [MAYNE PHARMA]	5	Current NDC, 2 package rows	20250425_eb18194f-2021-41fa-8bdf-31e0c0eb646b.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 ndc (product): 68308-752

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2055989	Annovera 0.15 MG / 0.013 MG per 24HR One Year Vaginal System	PSN	eb18194f-2021-41fa-8bdf-31e0c0eb646b	5
2055983	segesterone acetate 0.15 MG / ethinyl estradiol 0.013 MG per 24HR One Year Vaginal System	PSN	eb18194f-2021-41fa-8bdf-31e0c0eb646b	5
2055989	273 DAY ethinyl estradiol 0.000542 MG/HR / segesterone acetate 0.00625 MG/HR Vaginal System [Annovera]	SBD	eb18194f-2021-41fa-8bdf-31e0c0eb646b	5
2055983	273 DAY ethinyl estradiol 0.000542 MG/HR / segesterone acetate 0.00625 MG/HR Vaginal System	SCD	eb18194f-2021-41fa-8bdf-31e0c0eb646b	5
2055989	Annovera 0.15/0.013 MG per 24HR 273 Day Vaginal System	SY	eb18194f-2021-41fa-8bdf-31e0c0eb646b	5
2055983	ethinyl estradiol 0.013 MG / segesterone acetate 0.15 MG per 24HR 273 Day Vaginal System	SY	eb18194f-2021-41fa-8bdf-31e0c0eb646b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68308-752-01	68308075201	1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH	1 pouch	2024-08-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Annovera - Mayne Pharma \| Sever Pharma Solutions AB \| Sharp Packaging Services, LLC	Mayne Pharma \| Sever Pharma Solutions AB \| Sharp Packaging Services, LLC	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	5