Home NDC 50090-5458 Raloxifene Hydrochloride
Product NDC 50090-5458
11-digit product format 500905458
Labeler code 50090
Product ID 50090-5458_6ebda497-aa09-4efb-8136-223422b0f8a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raloxifene
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA090842
Marketing category ANDA
Marketing start 2016-06-29
Marketing end 0000-00-00
Substance RALOXIFENE HYDROCHLORIDE
Active strength 60 mg/1
Pharmacologic classes Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 30 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 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 50090-5458-1 1332a3947898…d4bfe170f9cd…
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 A090842-001 RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090842-001 AB
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 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090842-001 RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB 2014-09-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5458-1 Raloxifene Hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5458 RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 1 package rows 20210303_35b5e3e5-0dfe-4abe-a928-d91dedd450e1.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Raloxifene Hydrochloride RALOXIFENE American Health Packaging f5c25553-1546-451d-8069-c0f484c47741 2024-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE Aphena Pharma Solutions - Tennessee, LLC 53a2db10-4af8-4032-b598-b7c7a0969801 2021-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE HYDROCHLORIDE Exelan Pharmaceuticals, Inc. 2b94ecf5-d870-4132-b455-d5ee5c9dce56 2020-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842 Raloxifene Hydrochloride RALOXIFENE Cipla USA Inc. 8fef5bfd-a786-4442-b09b-f3b81812cdac 2020-09-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090842 application number: ANDA090842
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 50090-5458-1 50090545801 90 TABLET in 1 BOTTLE (50090-5458-1) 90 tablet 2021-01-29 0000-00-00 No No Current