Raloxifene hydrochloride

Product NDC: 50090-6177
11-digit product format: 500906177
Labeler code: 50090
Product ID: 50090-6177_88a25d54-f913-4a43-9f04-9ab1979ff633
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA211324
Marketing category: ANDA
Marketing start: 2017-12-30
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: 2026-12-31
Current FDA listing: Yes

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
A211324-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2020-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211324-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211324-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211324-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211324-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211324-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211324-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211324-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211324-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211324-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211324-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211324-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211324-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211324-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211324-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211324-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211324-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211324-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211324-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211324-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211324-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211324-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211324-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211324-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211324-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211324-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211324-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211324-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211324-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211324-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211324-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211324-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211324-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211324-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211324-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211324-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211324-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211324-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211324-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211324-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Raloxifene hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RALOXIFENE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4F86W47BR6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1490065	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
22a951ee-2ffc-4c60-b681-0f80285153e1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7ad62b49-6132-2a8c-4edd-73f39b2bf45c	Product name	6	20210312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6177-1	Raloxifene hydrochloride	90 in 1 BOTTLE	TABLET, COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6177-1	EA - Each	50090-6177	e3bc3de7-acdd-482d-adba-146b02c7100a	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6177	RALOXIFENE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]	4	Current NDC, Legacy NDC, 1 package rows	20231102_22a951ee-2ffc-4c60-b681-0f80285153e1.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 HYDROCHLORIDE	Bryant Ranch Prepack	7e4bfee5-fefc-4115-9bdb-222eccefca83	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	A-S Medication Solutions	22a951ee-2ffc-4c60-b681-0f80285153e1	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324 ndc (product): 50090-6177
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	a46bcc4f-f63d-4200-836d-a653a3c616db	2022-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	f0db29f5-28da-4165-94f8-24727b6b71e5	2022-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490065	raloxifene HCl 60 MG Oral Tablet	PSN	22a951ee-2ffc-4c60-b681-0f80285153e1	4
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	22a951ee-2ffc-4c60-b681-0f80285153e1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6177-1	50090617701	90 TABLET, COATED in 1 BOTTLE (50090-6177-1)	2022-10-18	0000-00-00	No	No	Current