Home NDC 72495-501 Intrarosa
Product NDC 72495-501
11-digit product format 724950501
Labeler code 72495
Product ID 72495-501_2b9876fb-e9e0-4dbc-e063-6294a90a8696
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasterone
Dosage form INSERT
Route VAGINAL
Labeler Millicent US, Inc.
Application NDA208470
Marketing category NDA
Marketing start 2020-11-01
Substance PRASTERONE
Active strength 6.5 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 72495-501 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72495-501 72495-501-14 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 Product TE source text 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# Additional Listing Data#
Finished product Yes
Brand name base Intrarosa
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRASTERONE 6.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 459AG36T1B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1927688 Internal RxNorm lookup 1927693 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72495-501-14 Intrarosa 14 in 1 BOX INSERT 14 5 72495-501-14 Intrarosa 1 in 1 BOX INSERT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72495-501 INTRAROSA (PRASTERONE) INSERT [MILLICENT US, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250114_ada639d4-bac0-2ad0-e053-2a95a90afce7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72495-501-14 72495050114 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK 1 box 2020-11-01 0000-00-00 No No Current