Raloxifene Hydrochloride

Product NDC: 71610-504
11-digit product format: 716100504
Labeler code: 71610
Product ID: 71610-504_b45bcef3-7e7d-4e6e-b181-80f89126bce5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078193
Marketing category: ANDA
Marketing start: 2014-03-28
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71610-504		I	Inactivated by FDA		2026-08-17
excluded package	package	71610-504	71610-504-60	I	Inactivated by FDA		2026-08-17

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 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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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	71610-504-60	`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
A078193-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078193-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`e64feba35796…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078193-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078193-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-504-60	2023-01-30	C162847	48780-1	f386c64a-461c-0266-e053-dadaa90a7c1a	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-504-60	Raloxifene Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-504-60	EA - Each	71610-504	31330ffa-4e6b-4a05-93cd-a1f75e905f96	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-504	RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20210129_a5102b05-a7b3-4b48-9ed8-a398cce78ea9.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 · 2 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	3568ed3c-6afd-4872-a861-93a7873bec9c	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078193 application number: ANDA078193
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e6be5b1d-757d-4bab-ad6a-c421960a104d	2021-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078193 application number: ANDA078193

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	a5102b05-a7b3-4b48-9ed8-a398cce78ea9	1
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	a5102b05-a7b3-4b48-9ed8-a398cce78ea9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-504-60	71610050460	90 TABLET, FILM COATED in 1 BOTTLE (71610-504-60)	2020-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Raloxifene Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2021-01-27	HUMAN PRESCRIPTION DRUG LABEL	1