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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5458IInactivated by FDA2026-08-17
excluded packagepackage50090-545850090-5458-1IInactivated by FDA2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5458-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5458-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5458-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5458-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5458-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5458-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5458-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5458-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5458-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-5458-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-5458-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-5458-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5458-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5458-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5458-11332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090842-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090842-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-243f01610625f2…
2019-09-15 20:21 UTC2019-09A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090842-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090842-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090842-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090842-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090842-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090842-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090842-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090842-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090842-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090842-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090842-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090842-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090842-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090842-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090842-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090842-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090842-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090842-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090842-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090842-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090842-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090842-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090842-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090842-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090842-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090842-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090842-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090842-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090842-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090842-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090842-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090842-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090842-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090842-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090842-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090842-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090842-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090842-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090842-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090842-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7ad62b49-6132-2a8c-4edd-73f39b2bf45cProduct name620210312
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5458-1Raloxifene Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5458RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210303_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENEAmerican Health Packagingf5c25553-1546-451d-8069-c0f484c477412024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENEAphena Pharma Solutions - Tennessee, LLC53a2db10-4af8-4032-b598-b7c7a09698012021-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEExelan Pharmaceuticals, Inc.2b94ecf5-d870-4132-b455-d5ee5c9dce562020-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
Raloxifene HydrochlorideRALOXIFENECipla USA Inc.8fef5bfd-a786-4442-b09b-f3b81812cdac2020-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN35b5e3e5-0dfe-4abe-a928-d91dedd450e11
1490065raloxifene hydrochloride 60 MG Oral TabletSCD35b5e3e5-0dfe-4abe-a928-d91dedd450e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5458-15009054580190 TABLET in 1 BOTTLE (50090-5458-1) 90 tablet2021-01-290000-00-00NoNoCurrent