Raloxifene Hydrochloride

Product NDC: 50090-3866
Requested package NDC: 50090-3866-1
11-digit product format: 500903866
Labeler code: 50090
Product ID: 50090-3866_833c033b-6909-427a-8dc2-230f31a554f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA208206
Marketing category: ANDA
Marketing start: 2016-01-20
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3866	50090-3866-1	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A208206-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2016-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208206-001	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	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208206-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-04-08	`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	A208206-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208206-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208206-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208206-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208206-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208206-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208206-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208206-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208206-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208206-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208206-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208206-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208206-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208206-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208206-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208206-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208206-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208206-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208206-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208206-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208206-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208206-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208206-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208206-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208206-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208206-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208206-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208206-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208206-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208206-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208206-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208206-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208206-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208206-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208206-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208206-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208206-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208206-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208206-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208206-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3866-0	2023-02-06	These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
50090-3866-1	2023-02-06	These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
50090-3866-0	2023-01-30	These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
50090-3866-1	2023-01-30	These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3866-1	EA - Each	50090-3866	c6527949-9532-4b8c-8f4d-15b7cccc59c1	1	2021-11-09

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	3798c70b-a4b0-4811-9788-e4c9cff47ebe	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208206 application number: ANDA208206
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	AvPAK	6f7eb934-aa60-51e1-e053-2a91aa0a3914	2026-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208206 application number: ANDA208206

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4F86W47BR6	RALOXIFENE HYDROCHLORIDE	82640-04-8	RALOXIFENE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3866-1	50090386601	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3866-1)	2016-01-20	0000-00-00	No	No	Current