Raloxifene Hydrochloride

Product NDC: 50090-5458
Requested package NDC: 50090-5458-1
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 15 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-5458	50090-5458-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090842-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090842-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090842-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090842-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090842-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090842-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090842-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090842-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090842-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090842-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090842-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090842-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090842-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090842-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090842-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090842-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090842-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090842-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090842-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090842-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090842-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090842-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090842-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090842-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090842-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090842-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090842-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090842-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090842-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090842-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090842-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090842-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090842-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090842-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090842-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090842-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090842-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090842-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090842-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090842-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7ad62b49-6132-2a8c-4edd-73f39b2bf45c	Product name	6	20210312
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5458-1	2023-01-30	C162847	48780-1	f386c64a-1867-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4F86W47BR6	RALOXIFENE HYDROCHLORIDE	82640-04-8	RALOXIFENE HYDROCHLORIDE
YX9162EO3I	RALOXIFENE	84449-90-1	Raloxifene

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490065	raloxifene HCl 60 MG Oral Tablet	PSN	35b5e3e5-0dfe-4abe-a928-d91dedd450e1	1
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	35b5e3e5-0dfe-4abe-a928-d91dedd450e1	1

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