Annovera

Product NDC: 68308-752
11-digit product format: 683080752
Labeler code: 68308
Product ID: 68308-752_0e93846a-09de-435e-a1db-0c87c7c74bb6
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: SEGESTERONE ACETATE; ETHINYL ESTRADIOL
Active strength: 103; 17.4 mg/1; mg/1
Pharmacologic classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	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#

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Annovera
Listing expiration: 2027-12-31

Active Ingredients#

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

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
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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

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

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	2026-09-17	HUMAN PRESCRIPTION DRUG LABEL	6