Intrarosa

Product NDC: 64011-601
11-digit product format: 640110601
Labeler code: 64011
Product ID: 64011-601_9bf80c3a-bb4a-4a90-8729-b2920ec3f620
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prasterone
Dosage form: INSERT
Route: VAGINAL
Labeler: AMAG Pharmaceuticals, Inc.
Application: NDA208470
Marketing category: NDA
Marketing start: 2017-07-24
Marketing end: 0000-00-00
Substance: PRASTERONE
Active strength: 7 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64011-601		I	Inactivated by FDA	2026-08-17
excluded package	package	64011-601	64011-601-14	I	Inactivated by FDA	2026-08-17
excluded package	package	64011-601	64011-601-28	I	Inactivated by FDA	2026-08-17

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 · 54 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	64011-601-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64011-601-14	`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	64011-601-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64011-601-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64011-601-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64011-601-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64011-601-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64011-601-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64011-601-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64011-601-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64011-601-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64011-601-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64011-601-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64011-601-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64011-601-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64011-601-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64011-601-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64011-601-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64011-601-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64011-601-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64011-601-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64011-601-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64011-601-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64011-601-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64011-601-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64011-601-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64011-601-28	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64011-601-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64011-601-28	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64011-601-14	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64011-601-14	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64011-601-28	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64011-601-14	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64011-601-28	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64011-601-14	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64011-601-28	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N208470-001	INTRAROSA	PRASTERONE	6.5MG	INSERT / VAGINAL		RLD, RS	2016-11-16

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208470-001	8629129	2028-08-07		Drug product	2016-12-08
N208470-001	8957054	2030-01-08	U-1922		2016-12-08
N208470-001	8268806	2031-03-19		Drug product	2016-12-08

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208470-001	NCE	2021-11-16	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208470-001	NCE	2021-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208470-001	NCE	2021-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208470-001	NCE	2021-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208470-001	NCE	2021-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208470-001	NCE	2021-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208470-001	NCE	2021-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208470-001	NCE	2021-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208470-001	NCE	2021-11-16	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86ca2ee7-106a-420e-9137-a9ec1af5dbc1	Product name	1	20170110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64011-601-14	2022-01-28	C162847	48780-1	d6a99b39-b39b-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use INTRAROSA ® safely and effectively. See full prescribing information for INTRAROSA ® . INTRAROSA ® (prasterone) vaginal inserts Initial U.S. Approval: 2016
64011-601-28	2022-01-28	C162847	48780-1	d6a99b39-b39b-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use INTRAROSA ® safely and effectively. See full prescribing information for INTRAROSA ® . INTRAROSA ® (prasterone) vaginal inserts Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64011-601-14	Intrarosa	14 in 1 BOX	INSERT	14	8
64011-601-14	Intrarosa	1 in 1 BOX	INSERT	1	8
64011-601-28	Intrarosa	28 in 1 BOX	INSERT	28	8
64011-601-28	Intrarosa	1 in 1 BOX	INSERT	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64011-601-28	EA - Each	64011-601	5d87c3c0-b2ed-4844-831f-a343f0a06102	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64011-601	INTRAROSA (PRASTERONE) INSERT [AMAG PHARMACEUTICALS, INC.]	8	Legacy NDC, 4 package rows	20201112_df731acd-7276-4fef-b037-bc7f30c112cb.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
Intrarosa	PRASTERONE	Millicent US, Inc.	ada639d4-bac0-2ad0-e053-2a95a90afce7	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208470 application number: NDA208470

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
459AG36T1B	PRASTERONE	53-43-0	PRASTERONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1927693	Intrarosa 6.5 MG Vaginal Insert	PSN	df731acd-7276-4fef-b037-bc7f30c112cb	8
1927688	prasterone 6.5 MG Vaginal Insert	PSN	df731acd-7276-4fef-b037-bc7f30c112cb	8
1927693	prasterone 6.5 MG Vaginal Insert [Intrarosa]	SBD	df731acd-7276-4fef-b037-bc7f30c112cb	8
1927688	prasterone 6.5 MG Vaginal Insert	SCD	df731acd-7276-4fef-b037-bc7f30c112cb	8
1927688	dehydroepiandrosterone (prasterone) 6.5 MG Vaginal Insert	SY	df731acd-7276-4fef-b037-bc7f30c112cb	8
1927693	Intrarosa (prasterone) 6.5 MG Vaginal Insert	SY	df731acd-7276-4fef-b037-bc7f30c112cb	8
1927693	Intrarosa 6.5 MG Vaginal Insert	SY	df731acd-7276-4fef-b037-bc7f30c112cb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64011-601-14	64011060114	1 BOX in 1 BOX (64011-601-14) > 14 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK	1 box	2017-07-24	0000-00-00	No	No	Current
64011-601-28	64011060128	1 BOX in 1 BOX (64011-601-28) > 28 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK	1 box	2017-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Intrarosa - AMAG Pharmaceuticals, Inc.	AMAG Pharmaceuticals, Inc.	2020-11-11	HUMAN PRESCRIPTION DRUG LABEL	8